Clinical Chemistry device product codes

526 FDA product codes. All panels.

• CCY — Zimmerman (Spectrophotometric), 17-Ketosteroids (Class I, 1 clearances)
• CCZ — Zimmerman/Norymberski, 17-Ketogenic Steroids (Class I, 1 clearances)
• CDA — Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin (Class I, 3 clearances)
• CDB — Porter Silber Hydrazone, 17-Hydroxycorticosteroids (Class I, 2 clearances)
• CDC — L-Leucyl B-Naphthylamide, Leucine Aminopeptidase (Class I)
• CDD — Radioassay, Vitamin B12 (Class II, 78 clearances)
• CDE — Chromatographic Separation/Zimmerman, 17-Ketosteroids (Class I)
• CDF — Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin (Class I, 12 clearances)
• CDG — Chromatography Separation/Zimmerman 17-Ketogenic Steroids (Class I, 1 clearances)
• CDH — Acid, Uric, Phosphotungstate Reduction (Class I, 15 clearances)
• CDK — Acid, Vanilmandelic, Electrophoretic Separation (Class I)
• CDL — Berthelot Indophenol, Urea Nitrogen (Class II, 16 clearances)
• CDM — Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) (Class I, 9 clearances)
• CDN — Urease, Photometric, Urea Nitrogen (Class II, 16 clearances)
• CDO — Acid, Uric, Uricase (U.V.) (Class I, 31 clearances)
• CDP — Radioimmunoassay, Total Triiodothyronine (Class II, 144 clearances)
• CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II, 117 clearances)
• CDR — 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine (Class I, 1 clearances)
• CDS — Electrode, Ion Specific, Urea Nitrogen (Class II, 15 clearances)
• CDT — Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (Class I, 151 clearances)
• CDW — Diacetyl-Monoxime, Urea Nitrogen (Class II, 21 clearances)
• CDX — Radioimmunoassay, Total Thyroxine (Class II, 121 clearances)
• CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I, 89 clearances)
• CEA — Tlc Chromatographic Separation Triglycerides (Class I)
• CEC — Radioimmunoassay, Free Thyroxine (Class II, 92 clearances)
• CED — 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase (Class I, 9 clearances)
• CEE — Radioimmunoassay, Thyroxine-Binding Globulin (Class II, 25 clearances)
• CEF — Electrophoretic, Protein Fractionation (Class I, 29 clearances)
• CEI — Uranyl Acetate/Zinc Acetate, Sodium (Class II, 4 clearances)
• CEJ — Tetraphenyl Borate, Colorimetry, Potassium (Class II, 16 clearances)
• CEK — Biuret (Colorimetric), Total Protein (Class II, 116 clearances)
• CEL — Ammonium Molybdate And Ammonium Vanadate, Phospholipids (Class I, 3 clearances)
• CEM — Electrode, Ion Specific, Potassium (Class II, 89 clearances)
• CEN — Dye-Indicator, Ph (Urinary, Non-Quantitative) (Class I, 11 clearances)
• CEO — Phosphomolybdate (Colorimetric), Inorganic Phosphorus (Class I, 105 clearances)
• CEP — Radioimmunoassay, Luteinizing Hormone (Class I, 143 clearances)
• CEQ — Molybdenum Blue Method, Phospholipids (Class I, 1 clearances)
• CER — 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase (Class II, 1 clearances)
• CES — Chromogenesis, Phenylketones (Urinary, Non-Quant.) (Class I)
• CET — Olive Oil Emulsion (Turbidimetric), Lipase (Class I, 15 clearances)
• CEW — Radioimmunoassay, Parathyroid Hormone (Class II, 86 clearances)
• CEX — Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (Class II, 8 clearances)
• CFA — Electrode, Ion Specific, Magnesium (Class I, 2 clearances)
• CFB — Chromatographic Derivative, Total Lipids (Class I)
• CFD — Sulfophosphovanillin, Colorimetry, Total Lipids (Class I, 4 clearances)
• CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II, 28 clearances)
• CFG — Oil Emulsion/Thymolphthalein (Titrimetric), Lipase (Class I, 2 clearances)
• CFH — Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase (Class II, 13 clearances)
• CFJ — Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (Class II, 111 clearances)
• CFL — Radioimmunoassay, Human Growth Hormone (Class I, 36 clearances)
• CFM — Bathophenanthroline, Colorimetry, Iron (Non-Heme) (Class I, 21 clearances)
• CFO — Titrimetric, Magnesium (Class I)
• CFP — Radioimmunoassay, Immunoreactive Insulin (Class I, 27 clearances)
• CFR — Hexokinase, Glucose (Class II, 145 clearances)
• CFT — Radioimmunoassay, Prolactin (Lactogen) (Class I, 80 clearances)
• CFW — Copper Reduction, Glucose (Class II)
• CGA — Glucose Oxidase, Glucose (Class II, 401 clearances)
• CGC — Radioimmunoassay, Gastrin (Class I, 10 clearances)
• CGD — Ferricyanide, Glucose (Class II)
• CGE — Orthotoluidine, Glucose (Class II, 12 clearances)
• CGF — Radioimmunoassay, Estrone (Class I, 4 clearances)
• CGH — Electrophoretic, Globulin (Class I)
• CGI — Radioimmunoassay, Estriol (Class I, 42 clearances)
• CGJ — Radioimmunoassay, Follicle-Stimulating Hormone (Class I, 88 clearances)
• CGL — Electrode, Ion Based, Enzymatic, Creatinine (Class II, 7 clearances)
• CGN — Acid, Folic, Radioimmunoassay (Class II, 64 clearances)
• CGO — Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol (Class I, 11 clearances)
• CGR — Radioimmunoassay, Cortisol (Class II, 84 clearances)
• CGS — Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (Class II, 123 clearances)
• CGT — Radioimmunoassay, Cyclic Gmp (Class II)
• CGX — Alkaline Picrate, Colorimetry, Creatinine (Class II, 159 clearances)
• CGZ — Electrode, Ion-Specific, Chloride (Class II, 38 clearances)
• CHA — Radioimmunoassay, Corticosterone (Class I)
• CHC — Titrimetric Permanganate And Bromophenol Blue, Calcium (Class II)
• CHD — Acid, Ferric Ion-Sulfuric, Cholesterol (Class I, 3 clearances)
• CHE — Radioimmunoassay, Corticoids (Class I)
• CHG — Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride (Class II, 3 clearances)
• CHH — Enzymatic Esterase--Oxidase, Cholesterol (Class I, 230 clearances)
• CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase (Class I, 20 clearances)
• CHJ — Mercuric Thiocyanate, Colorimetry, Chloride (Class II, 53 clearances)
• CHK — Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride (Class II, 1 clearances)
• CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (Class II, 188 clearances)
• CHM — Radioimmunoassay, Total Estrogens In Pregnancy (Class I)
• CHO — Radioimmunoassay, Cyclic Amp (Class II, 6 clearances)
• CHP — Radioimmunoassay, Estradiol (Class I, 50 clearances)
• CHQ — Chromatographic/Fluorometric Method, Catecholamines (Class I, 10 clearances)
• CHR — Titrimetric Phenol Red, Carbon-Dioxide (Class II)
• CHS — Coulometric Method, Carbon-Dioxide (Class II, 6 clearances)
• CHT — Electrophoretic Method, Catecholamines (Class I, 2 clearances)
• CHW — Titrimetric With Edta And Indicator, Calcium (Class II, 3 clearances)
• CHZ — Di (O-Hydroxyphenylimine) Ethane, Calcium (Class II, 1 clearances)
• CIA — Methylthymol Blue, Calcium (Class II, 5 clearances)
• CIB — Radioimmunoassay, Angiotensin I And Renin (Class II, 16 clearances)
• CIC — Cresolphthalein Complexone, Calcium (Class II, 99 clearances)
• CID — Alizarin Sulfonate, Calcium (Class II, 2 clearances)
• CIE — Volumetric/Manometric, Carbon-Dioxide (Class II, 7 clearances)
• CIF — Vanillin Pyruvate, Ast/Sgot (Class II, 1 clearances)
• CIG — Diazo Colorimetry, Bilirubin (Class II, 235 clearances)
• CIJ — Saccharogenic, Amylase (Class II, 31 clearances)
• CIK — Radial Diffusion, Amylase (Class II)
• CIL — Cresol Red Colorimetry, Carbon-Dioxide (Class II, 4 clearances)
• CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II, 26 clearances)
• CIO — Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II, 11 clearances)
• CIQ — Diazo, Ast/Sgot (Class II, 7 clearances)
• CIS — Hydrazone Colorimetry, Ast/Sgot (Class II, 5 clearances)
• CIT — Nadh Oxidation/Nad Reduction, Ast/Sgot (Class II, 139 clearances)
• CIW — Starch-Dye Bound Polymer, Amylase (Class II, 8 clearances)
• CIX — Bromcresol Green Dye-Binding, Albumin (Class II, 120 clearances)
• CIY — Radioimmunoassay, Androsterone (Class I, 1 clearances)
• CIZ — Radioimmunoassay, Androstenedione (Class I, 10 clearances)
• CJA — Amyloclastic, Amylase (Class II, 10 clearances)
• CJB — Chromatographic Separation/Radioimmunoassay, Aldosterone (Class II)
• CJC — Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase (Class I)
• CJD — Nitrosalicylate Reduction, Amylase (Class II, 1 clearances)
• CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II, 124 clearances)
• CJF — Tetrabromophenolphthalein, Albumin (Class II, 1 clearances)
• CJG — Tetrabromo-M-Cresolsulfonphthalein, Albumin (Class II, 1 clearances)
• CJH — Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II, 1 clearances)
• CJI — Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II)
• CJJ — Diazo, Alt/Sgpt (Class I, 2 clearances)
• CJK — Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes (Class II, 1 clearances)
• CJL — Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes (Class II, 1 clearances)
• CJM — Radioimmunoassay, Aldosterone (Class II, 12 clearances)
• CJN — Acid Phosphatase, Nitrophenylphosphate (Class II, 1 clearances)
• CJO — Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes (Class II, 4 clearances)
• CJQ — Radial Immunodiffusion, Albumin (Class II, 1 clearances)
• CJR — Acid Phosphatase, Thymol Blue Monophosphate (Class II, 2 clearances)
• CJT — Hydrazone Colorimetry, Aldolase (Class I, 1 clearances)
• CJW — Bromcresol Purple Dye-Binding, Albumin (Class II, 18 clearances)
• CJX — Acid Phosphatase, Disodium Phenylphosphate (Class II)
• CJY — Azo Dye, Calcium (Class II, 47 clearances)
• CJZ — Acid, Hydroxyazobenzene-Benzoic, Albumin (Class II)
• CKA — Nadh Oxidation/Nad Reduction, Alt/Sgpt (Class I, 127 clearances)
• CKB — Acid Phosphatase, Naphthyl Phosphate (Class II, 24 clearances)
• CKC — Vanillin Pyruvate, Alt/Sgpt (Class I, 2 clearances)
• CKD — Hydrazone Colorimetry, Alt/Sgpt (Class I, 11 clearances)
• CKE — Acid Phosphatase, Thymolphthale Inmonophosphate (Class II, 9 clearances)
• CKF — Phenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II, 2 clearances)
• CKG — Radioimmunoassay, Acth (Class II, 30 clearances)
• CKH — Acid Phosphatase, Beta Glycerophosphate (Class II)
• DHA — System, Test, Human Chorionic Gonadotropin (Class II, 72 clearances)
• GIM — Tubes, Vacuum Sample, With Anticoagulant (Class II, 39 clearances)
• GJE — Tray, Blood Collection (Class II, 7 clearances)
• GLE — Mixer, Blood Tube (Class I, 5 clearances)
• JBS — Timer, General Laboratory (Class I)
• JFH — Acid Phosphatase (Prostatic), Tartrate Inhibited (Class II, 45 clearances)
• JFJ — Catalytic Methods, Amylase (Class II, 99 clearances)
• JFL — Ph Rate Measurement, Carbon-Dioxide (Class II, 28 clearances)
• JFM — Enzymatic Method, Bilirubin (Class II, 11 clearances)
• JFN — Atomic Absorption, Calcium (Class II, 3 clearances)
• JFO — Fluorometric, Calcium (Class II, 1 clearances)
• JFP — Electrode, Ion Specific, Calcium (Class II, 29 clearances)
• JFS — Coulometric, Chloride (Class II, 19 clearances)
• JFT — Fluorometric, Cortisol (Class II, 20 clearances)
• JFY — Enzymatic Method, Creatinine (Class II, 49 clearances)
• JGC — Tryptophan Measurement (Colorimetric), Globulin (Class I)
• JGD — Nephelometric Method, Globulin (Class I)
• JGE — Turbidimetric Method, Globulin (Class I, 1 clearances)
• JGF — Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (Class II, 6 clearances)
• JGG — L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase (Class I, 2 clearances)
• JGI — Atomic Absorption, Magnesium (Class I)
• JGJ — Photometric Method, Magnesium (Class I, 90 clearances)
• JGK — Ferric Chloride, Phenylketones (Urinary, Non-Quant.) (Class I)
• JGM — Flame Photometry, Potassium (Class II, 5 clearances)
• JGP — Lowry (Colorimetric), Total Protein (Class II, 5 clearances)
• JGQ — Turbidimetric, Total Protein (Class II, 13 clearances)
• JGR — Refractometric, Total Protein (Class II)
• JGS — Electrode, Ion Specific, Sodium (Class II, 162 clearances)
• JGT — Flame Photometry, Sodium (Class II, 8 clearances)
• JGW — Fluorometric Method, Triglycerides (Class I, 3 clearances)
• JGX — Turbidimetric Method, Triglycerides (Class I, 1 clearances)
• JGY — Colorimetric Method, Triglycerides (Class I, 22 clearances)
• JGZ — O-Phthalaldehyde, Urea Nitrogen (Class II, 11 clearances)
• JHA — Acid, Uric, Uricase (Gasometric) (Class I)
• JHC — Acid, Uric, Uricase (Oxygen Rate) (Class I, 1 clearances)
• JHD — Fluorometric Method, 17-Hydroxycorticosteroids (Class I)
• JHE — Radioassay, 17-Hydroxycorticosteroids (Class I)
• JHF — Colorimetric Method, Lecithin/Sphingomyelin Ratio (Class II, 2 clearances)
• JHG — Chromatographic Separation, Lecithin/Sphingomyelin Ratio (Class II, 7 clearances)
• JHH — Electrophoretic Method, Lecithin/Sphingomyelin Ratio (Class II)
• JHI — Visual, Pregnancy Hcg, Prescription Use (Class II, 375 clearances)
• JHJ — Agglutination Method, Human Chorionic Gonadotropin (Class II, 96 clearances)
• JHL — Microdensitometry Method, Lipoproteins (Class I, 1 clearances)
• JHM — Colorimetric Method, Lipoproteins (Class I, 9 clearances)
• JHN — Turbidimetric Method, Lipoproteins (Class I, 7 clearances)
• JHO — Electrophoretic Separation, Lipoproteins (Class I, 26 clearances)
• JHP — Radial Immunodiffusion, Lipoproteins (Class I)
• JHQ — Nephelometric Method, Lipoproteins (Class I, 1 clearances)
• JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II, 38 clearances)
• JHT — Chromatographic Separation, Cpk Isoenzymes (Class II, 21 clearances)
• JHW — U.V. Method, Cpk Isoenzymes (Class II, 27 clearances)
• JHX — Fluorometric Method, Cpk Or Isoenzymes (Class II, 48 clearances)
• JHY — Colorimetric Method, Cpk Or Isoenzymes (Class II, 40 clearances)
• JIA — Enzymatic Methods, Galactose (Class I, 9 clearances)
• JIB — U.V. Method, Galactose (Class I)
• JIC — Colorimetric Method, Galactose (Class I)
• JID — Photometric Method, Ammonia (Class I, 3 clearances)
• JIE — Method, Ion-Exchange, Ammonia (Class I)
• JIF — Enzymatic Method, Ammonia (Class I, 30 clearances)
• JIG — Electrode, Ion-Specific Method, Ammonia (Class I)
• JIJ — Wet Ash Method, Protein-Bound Iodine (Class I)
• JIK — Dry Ash Method, Protein-Bound Iodine (Class I)
• JIL — Method, Enzymatic, Glucose (Urinary, Non-Quantitative) (Class II, 81 clearances)
• JIM — Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) (Class II, 2 clearances)
• JIN — Nitroprusside, Ketones (Urinary, Non-Quant.) (Class I, 24 clearances)
• JIQ — Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) (Class I, 13 clearances)
• JIR — Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (Class I, 38 clearances)
• JIS — Calibrator, Primary (Class II, 130 clearances)
• JIT — Calibrator, Secondary (Class II, 245 clearances)
• JIW — Calibrator, Surrogate (Class II, 17 clearances)
• JIX — Calibrator, Multi-Analyte Mixture (Class II, 302 clearances)
• JIY — Photometric Method, Iron (Non-Heme) (Class I, 67 clearances)
• JIZ — Atomic Absorption, Iron (Non-Heme) (Class I)
• JJA — Radio-Labeled Iron Method, Iron (Non-Heme) (Class I, 4 clearances)
• JJB — Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) (Class I, 5 clearances)
• JJC — Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use (Class I, 32 clearances)
• JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (Class I, 208 clearances)
• JJF — Analyzer, Chemistry, Micro, For Clinical Use (Class I, 57 clearances)
• JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use (Class I, 30 clearances)
• JJH — Clinical Sample Concentrator (Class I, 15 clearances)
• JJI — Analyzer, Enzyme, For Clinical Use (Class I, 8 clearances)
• JJJ — Counter (Beta, Gamma) For Clinical Use (Class I, 63 clearances)
• JJK — Oncometer, Plasma, For Clinical Use (Class I, 4 clearances)
• JJL — Plasma Viscometer For Clinical Use (Class I, 1 clearances)
• JJM — Osmometer For Clinical Use (Class I, 12 clearances)
• JJN — Apparatus, Electrophoresis, For Clinical Use (Class I, 34 clearances)
• JJO — Flame Emission Photometer For Clinical Use (Class I, 22 clearances)
• JJP — Electrode, Ion Selective (Non-Specified) (Class I, 3 clearances)
• JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I, 258 clearances)
• JJR — Electrolyte Controls (Assayed And Unassayed) (Class I, 17 clearances)
• JJS — Controls For Blood-Gases, (Assayed And Unassayed) (Class I, 67 clearances)
• JJT — Enzyme Controls (Assayed And Unassayed) (Class I, 97 clearances)
• JJW — Urinalysis Controls (Assayed And Unassayed) (Class I, 61 clearances)
• JJX — Single (Specified) Analyte Controls (Assayed And Unassayed) (Class I, 493 clearances)
• JJY — Multi-Analyte Controls, All Kinds (Assayed) (Class I, 673 clearances)
• JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II, 235 clearances)
• JKB — Radioimmunoassay, Compound S (11-Deoxycortisol) (Class I, 1 clearances)
• JKC — Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) (Class I, 28 clearances)
• JKD — Radioimmunoassay, C-Peptides Of Proinsulin (Class I, 10 clearances)
• JKF — Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge (Class I, 2 clearances)
• JKG — L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase (Class I, 1 clearances)
• JKH — Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen (Class I, 1 clearances)
• JKJ — Fluorometric Measurement, Porphyrins (Class I, 3 clearances)
• JKL — Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry (Class I, 2 clearances)
• JKP — Chromium-51, Blood Volume (Class I, 1 clearances)
• JKR — Radioimmunoassay, Calcitonin (Class II, 20 clearances)
• JKW — N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin (Class I)
• JKX — N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin (Class I)
• JKY — Oxalydihydrazide (Spectroscopic), Copper (Class I)
• JKZ — Diethyldithiocarbamate (Colorimetric), Copper (Class I)
• JLA — Conversion To Creatinine, Creatine (Class I, 2 clearances)
• JLB — Atp And Creatine Kinase (Enzymatic), Creatine (Class I, 3 clearances)
• JLC — Nitroprusside Reaction (Qualitative, Urine), Cystine (Class I, 2 clearances)
• JLD — Chromatographic, Cystine (Class I)
• JLE — Radioimmunoassay, Desoxycorticosterone (Class I)
• JLF — Radioimmunoassay, Etiocholanolone (Class I)
• JLG — Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids (Class I, 2 clearances)
• JLH — Titrimetric, Fatty Acids (Class I, 1 clearances)
• JLI — Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid (Class I)
• JLJ — Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate (Class II, 1 clearances)
• JLK — Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity (Class I)
• JLL — Tubeless Analysis, Gastric Acidity (Class I)
• JLN — Chromatographic, Glutathione (Class I)
• JLO — Enzymatic (Glutathione Reductase), Glutathione (Class I)
• JLP — Spectrophotometric Method, Pregnanediol (Class I, 1 clearances)
• JLQ — Spectrophotometric Method, Pregnanetriol (Class I)
• JLR — Gas Chromatography, Pregnanetriol (Class I)
• JLS — Radioimmunoassay, Progesterone (Class I, 57 clearances)
• JLT — Acid, Pyruvic, Enzymatic (U.V.) (Class I)
• JLW — Radioimmunoassay, Thyroid-Stimulating Hormone (Class II, 242 clearances)
• JLX — Radioimmunoassay, 17-Hydroxyprogesterone (Class I, 19 clearances)
• JLY — Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid (Class I)
• JLZ — Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid (Class I)
• JMA — Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (Class I, 3 clearances)
• JMD — Radioimmunoassay, Total Estrogens, Nonpregnancy (Class I, 2 clearances)
• JME — Radioimmunoassay, Glucagon (Class I, 3 clearances)
• JMF — Radioimmunoassay, Human Placental Lactogen (Class II, 11 clearances)
• JMG — Radioimmunoassay (Two-Site Solid Phase), Ferritin (Class II, 24 clearances)
• JMI — Chromatographic, Histidine (Class I)
• JMJ — Microbiological, Histidine (Class I)
• JMK — Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase (Class I, 16 clearances)
• JMM — Column Chromatography & Color Development, Hydroxyproline (Class I, 21 clearances)
• JMN — Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline (Class I)
• JMO — Ferrozine (Colorimetric) Iron Binding Capacity (Class I, 46 clearances)
• JMQ — M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) (Class I)
• JMR — Immunochemical, Lysozyme (Muramidase) (Class I)
• JMS — Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase (Class I)
• JMT — Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (Class I, 13 clearances)
• JMW — 2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen) (Class I)
• JMX — Ninhydrin, Nitrogen (Amino-Nitrogen) (Class I, 2 clearances)
• JMY — Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase (Class I)
• JMZ — Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality (Class I, 2 clearances)
• JNA — Vapor Pressure, Osmolality Of Serum & Urine (Class I)
• JNB — Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine (Class II, 15 clearances)
• JNC — Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine (Class II)
• JND — Nadp Reduction, 6-Phosphogluconate Dehydrogenase (Class I)
• JNE — Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase (Class I)
• JNF — Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen (Class I, 1 clearances)
• JNG — Radioimmunoassay, Pregnenolone (Class I)
• JNJ — Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase (Class I)
• JNK — Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase (Class I)
• JNN — P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin (Class I)
• JNO — N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin (Class I, 7 clearances)
• JNP — Infrared Spectroscopy Measurement, Urinary Calculi (Stone) (Class I)
• JNQ — Qualitative Chemical Reactions, Urinary Calculi (Stone) (Class I)
• JNS — Stannous Chloride - Hydrazine, Phospholipids (Class I)
• JNT — Chromatographic, Phospholipids (Class I, 3 clearances)
• JNX — Membrane Osmometry, Plasma Oncometry (Class I)
• JNY — Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase (Class I)
• JNZ — Fluorometric, Uroporphyrin (Class I)
• JOA — Acid, Trifluoroacetic, Vitamin A, Hexane Extraction (Class I)
• JOB — Hexane Extraction, Fluorescence, Vitamin E (Class I, 1 clearances)
• JOC — Colorimetric, Xylose (Class I, 1 clearances)
• JPZ — Colorimetric Method, Gamma-Glutamyl Transpeptidase (Class I, 33 clearances)
• JQA — Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes (Class I)
• JQB — Kinetic Method, Gamma-Glutamyl Transpeptidase (Class I, 52 clearances)
• JQC — Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (Class I, 38 clearances)
• JQD — Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity (Class I)
• JQE — Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (Class I, 6 clearances)
• JQF — Bathophenanthroline, Iron Binding Capacity (Class I, 8 clearances)
• JQG — Radiometric, Fe59, Iron Binding Capacity (Class I, 5 clearances)
• JQH — Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen) (Class I)
• JQI — Rotating Disc, Plasma Viscometry (Class I)
• JQJ — Densitometeric, Protein Fractionation (Class I, 1 clearances)
• JQK — Immunodiffusion, Protein Fractionation (Class I, 1 clearances)
• JQL — Spectrophotometric, Uroporphyrin (Class I)
• JQM — P-Bromoaniline, Xylose (Class I)
• JQN — Colorimetric, Mucopolysaccharides (Class I, 2 clearances)
• JQO — Balance, Analytical (Class I)
• JQP — Calculator/Data Processing Module, For Clinical Use (Class I, 78 clearances)
• JQQ — Dialyzer (Class I, 1 clearances)
• JQT — Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I, 18 clearances)
• JQW — Station, Pipetting And Diluting, For Clinical Use (Class I, 140 clearances)
• JQX — Nephelometer, For Clinical Use (Class I, 14 clearances)
• JQY — Ph Meter (Class I, 8 clearances)
• JQZ — Polarimeter (Class I, 1 clearances)
• JRA — Microtitrator, For Clinical Use (Class I, 1 clearances)
• JRB — Micro Mixer (Class I)
• JRC — Micro Pipette (Class I, 6 clearances)
• JRE — Refractometer For Clinical Use (Class I, 13 clearances)
• JRG — Block, Heating (Class I, 3 clearances)
• JRI — Cuvette, Thermostated (Class I, 4 clearances)
• JRJ — Unit, Drying (Class I, 1 clearances)
• JRK — Evaporator (Class I)
• JRL — Unit, Filter, Membrane (Class I, 9 clearances)
• JRM — Freezer (Class I, 7 clearances)
• JRO — Blender/Mixer (Class I)
• JRQ — Shaker/Stirrer (Class I, 8 clearances)
• JRR — Regulator, Temperature (Class I, 4 clearances)
• JRS — Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) (Class I)
• KHM — Nephelometric, Amylase (Class II, 6 clearances)
• KHO — Fluorometer, For Clinical Use (Class I, 38 clearances)
• KHP — Acid, Lactic, Enzymatic Method (Class I, 27 clearances)
• KHQ — Radioassay, Triiodothyronine Uptake (Class II, 93 clearances)
• KHS — Enzymatic, Carbon-Dioxide (Class II, 86 clearances)
• KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (Class II, 86 clearances)
• KLJ — Nad Reduction (U.V.), Phosphohexose Isomerase (Class I, 1 clearances)
• KMS — Phenolphthalein Colorimetry, Carbon-Dioxide (Class II, 5 clearances)
• KNK — Acid, Uric, Uricase (Colorimetric) (Class I, 118 clearances)
• KQN — Radioassay, Angiotensin Converting Enzyme (Class II, 8 clearances)
• KQO — Automated Urinalysis System (Class I, 46 clearances)
• KQP — Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase (Class II, 7 clearances)
• KWW — Radioimmunoassay, Cholyglycine, Bile Acids (Class II, 6 clearances)
• KWX — Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids (Class II, 2 clearances)
• LBR — Ldl & Vldl Precipitation, Hdl (Class I, 66 clearances)
• LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (Class I, 80 clearances)
• LBT — Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl (Class I, 8 clearances)
• LCH — Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical (Class I, 9 clearances)
• LCI — Automated Radioimmunoassay Systems, For Clinical Use (Class I, 3 clearances)
• LCX — Kit, Test, Pregnancy, Hcg, Over The Counter (Class II, 226 clearances)
• LFP — Conductivity Rate, Urea Nitrogen (Class II, 6 clearances)
• LFQ — Acid, Uric, Acid Reduction Of Ferric Ion (Class I, 5 clearances)
• LFR — Glucose Dehydrogenase, Glucose (Class II, 73 clearances)
• LFS — Radioreceptor Assay, Human Chorionic Gonadotropin (Class II)
• LHE — Controller, Closed-Loop Blood Glucose (Class III)
• LIG — Radioassay, Intrinsic Factor Blocking Antibody (Class II, 8 clearances)
• LKV — Enzyme Immunoassay, Fetal Fibronectin (Class III)
• LMY — Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions (Class III)
• LPI — Kit, Assay, Progesterone Receptor (Class III)
• LPJ — Kit, Assay, Estrogen Receptor (Class III)
• LPS — Urinary Homocystine (Nonquantitative) Test System (Class II, 29 clearances)
• LPT — System, Test, Urinary Methylmalonic Acid (Class II)
• LPW — System, Test, Oxalate (Class I, 1 clearances)
• LTC — Hyaline Membrane Disease Assay (Class III, 1 clearances)
• LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (Class I, 3 clearances)
• LZF — Pump, Infusion, Analytical Sampling (Class II, 7 clearances)
• LZG — Pump, Infusion, Insulin (Class II, 84 clearances)
• MDS — Sensor, Glucose, Invasive (Class III)
• MMI — Immunoassay Method, Troponin Subunit (Class II, 94 clearances)
• MPG — Urinary Carbohydrate Analysis Kit (Class I, 1 clearances)
• MPQ — Container, Specimen, Urine, Drugs Of Abuse, Over The Counter (Class I)
• MQM — Bilirubin (Total And Unbound) In The Neonate Test System (Class I, 17 clearances)
• MRG — System, Test, Vitamin D (Class II, 46 clearances)
• MRR — System, Test, Low Density, Lipoprotein (Class I, 31 clearances)
• MRV — Drink, Glucose Tolerance (Class II, 3 clearances)
• MSJ — Apolipoproteins (Class I, 50 clearances)
• MSM — System, Test, Lipoprotein(A) (Class I)
• MWQ — System, Test, Total Antioxidant Status (Class III)
• MXA — System, Test, Breath Nitric Oxide (Class II, 15 clearances)
• MXB — Test, Vaginal, Bacterial Sialidase (Class I, 2 clearances)
• MXT — Device, Accessory, Cooling Plate For Tissue Embedding Station (Class I)
• MYT — Biosensor, Immunoassay, Cpk Or Isoenzymes (Class II, 3 clearances)
• MZU — System, Test, Sodium, Enzymatic Method (Class II, 2 clearances)
• MZV — Test, System, Potassium, Enzymatic Method (Class II, 4 clearances)
• NAK — System, Test, Biotinidase (Class II, 5 clearances)
• NAL — Test, Immunoassay, Biosensor, Hcg (Class II, 2 clearances)
• NAO — Test, Carbohydrate Deficient Transferrin (Class I, 3 clearances)
• NAQ — Lipoprotein, High Density, Hdl, Over The Counter (Class I, 2 clearances)
• NBC — Test, Natriuretic Peptide (Class II, 45 clearances)
• NBW — System, Test, Blood Glucose, Over The Counter (Class II, 508 clearances)
• NCT — Instrument, Glucose, Noninvasive Technology (Class III)
• NDC — Calculator, Drug Dose (Class II, 54 clearances)
• NDR — Enzyme Immunoassay, Inhibin-A (Class I, 1 clearances)
• NDY — Test, Cystatin C (Class II, 22 clearances)
• NEO — System, Test, Osteocalcin (Class II, 2 clearances)
• NHG — Enzyme Immunoassay, Cortisol, Salivary (Class II, 7 clearances)
• NJV — Test, Albumin Cobalt Binding (Class II, 2 clearances)
• NQC — Test, Breath Analysis, Volatile Organic Compounds (HDE)
• NQL — System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry (Class II, 5 clearances)
• NQM — Immunoassay For Detection Of Amniotic Fluid Protein(S). (Class I, 2 clearances)
• NRH — System, Breath Measurement (Class I, 4 clearances)
• NSU — Instrumentation For Clinical Multiplex Test Systems (Class II, 13 clearances)
• NUK — For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System (Not classified)
• NUL — For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System (Not classified)
• NVV — Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System (Class I)
• OAM — Immunoassay, Insulin-Like Growth Factor Binding Protein-1 (Class I, 2 clearances)
• OHQ — Multi-Analyte Controls Unassayed (Class I)
• OHZ — Urine Transport Kit (Excludes Hiv Testing) (Class I)
• OIA — Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) (Class I)
• OIB — Blood And Urine Collection Kit (Excludes Hiv Testing) (Class I)
• OIC — Blood Alcohol Kit (Excludes Hiv Testing) (Class II)
• OID — Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) (Class I)
• OIE — Urine Collection Kit (Excludes Hiv Testing) (Class I)
• OJQ — Cardiac Allograft Gene Expression Profiling Test System (Class II, 2 clearances)
• OLD — Internal Polymerase Chain Reaction Control, Not Assay Specific (Class I, 1 clearances)
• OND — Osmolality Of Tears (Class I, 1 clearances)
• OOI — Real Time Nucleic Acid Amplification System (Class II, 14 clearances)
• OPP — Pump, Infusion, Insulin Bolus (Class II, 7 clearances)
• OSX — Galectin-3 In Vitro Diagnostic Assay (Class II, 2 clearances)
• OTA — Mass Spectrometer For Clinical Multiplex Test Systems (Class II)
• OTV — Research Use Only/Clinical Chemistry Devices (Not classified)
• OUL — Thermocycler, Generic (Class I)
• OVA — Complete Gene Expression Profiling Accessory Reagents (Class II, 1 clearances)
• OYC — Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (Class III)
• OYG — St2 Assay (Class II, 1 clearances)
• OYJ — Dna Specimen Collection, Saliva (Class II, 7 clearances)
• OZO — Automated Insulin Dosing , Threshold Suspend (Class III)
• OZP — Automated Insulin Dosing Device System, Single Hormonal Control (Class III)
• OZQ — Automated Insulin Dosing Device System, Bihormonal Control (Class III)
• PAQ — Test, Nr2 Antibody (Not classified)
• PAR — Test, Volatile Organic Compounds Breath Analysis (HDE)
• PCA — Dna Genetic Analyzer (Class II, 1 clearances)
• PDA — Investigational Use Only - Clinical Chemistry (Not classified)
• PDJ — Hemoglobin A1c Test System (Class II, 26 clearances)
• PDS — Amniotic Fluid Protein Immunoassay (Class I)
• PEG — Nucleic Acid Quantitation Kit (Class I)
• PEJ — Salivary Estriol Test (Class III)
• PER — Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (Class I, 3 clearances)
• PFQ — Mmp-9 Test System (Class I, 1 clearances)
• PHG — Droplet Digital Pcr System (Class II)
• PHK — Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation (Not classified)
• PHV — Continuous Glucose Monitor Retrospective Data Analysis Software (Class I, 1 clearances)
• PIG — Acute Kidney Injury Test System (Class II, 5 clearances)
• PJC — Newborn Screening Specimen Collection Paper (Class II, 2 clearances)
• PJD — Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (Class II, 9 clearances)
• PJE — Blood/Plasma Collection Device For Dna Testing (Class II, 8 clearances)
• PJT — Continuous Glucose Monitor Secondary Display (Class II, 2 clearances)
• PKU — Insulin Pump Secondary Display (Class II)
• PQD — Blood Specimen Collection Convenience Kit (Excludes Hiv) (Class II)
• PQF — Sensor, Glucose, Invasive, Non-Adjunctive (Class III)
• PQT — Alpha-L-Iduronidase (Idua) Newborn Screening Test System (Class II)
• PQU — Alpha-D-Glucosidase (Gaa) Newborn Screening Test System (Class II)
• PQV — ß-Glucocerebrosidase (Gba) Newborn Screening Test System (Class II)
• PQW — Alpha-D-Galactosidase A (Gla) Newborn Screening Test System (Class II, 3 clearances)
• PRJ — Capillary Blood Collection Device For Alternative Site Collection (Class II, 2 clearances)
• PSL — 25-Oh-Vitamin D Mass Spectrometry Test System (Class II, 1 clearances)
• PSM — Refractometer For Donor Testing (Class I)
• PTC — Uric Acid Test System For At Home Prescription Use (Class I, 3 clearances)
• PYP — Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test (Class I, 1 clearances)
• PYV — Hospital Continuous Glucose Monitoring System (Class II)
• PZE — Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (Class III)
• PZI — Prescription Use Blood Glucose Meter For Near-Patient Testing (Class II, 13 clearances)
• QBJ — Integrated Continuous Glucose Monitoring System, Factory Calibrated (Class II, 17 clearances)
• QBZ — Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma (Class I)
• QCC — Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals (Class II, 5 clearances)
• QCD — Continuous Glucose Monitor, Implanted, Adjunctive Use (Class III)
• QCL — Acid-Sphingomyelinase (Asm) Newborn Screening Test System (Class II)
• QCM — ß-Galactocerebrosidase (Galc) Newborn Screening Test System (Class II)
• QDH — Menopause Test System (Class II, 1 clearances)
• QDJ — Direct-To-Consumer Access Pharmacogenetic Assessment System (Class II, 3 clearances)
• QDK — Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management (Class II, 4 clearances)
• QDL — Integrated Continuous Glucose Monitoring System For Professional Retrospective Use (Class II, 1 clearances)
• QEI — Breast Milk Macronutrients Test System (Class II, 3 clearances)
• QFG — Alternate Controller Enabled Insulin Infusion Pump (Class II, 27 clearances)
• QHJ — Sensor, Glucose, Implanted, Non-Adjunctive Use (Class III)
• QII — Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use (Class II, 1 clearances)
• QJE — Muscular Dystrophy Newborn Screening Test (Class II, 1 clearances)
• QJI — Interoperable Automated Glycemic Controller (Class II, 20 clearances)
• QJS — Interoperable Automated Glycemic Controller, Insulin Suspend (Class II, 1 clearances)
• QLG — Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (Class II, 9 clearances)
• QMA — Blood Collection Device For Cell-Free Nucleic Acid (Class II, 2 clearances)
• QQB — Prognostic Test For Assessment Of Liver Related Disease Progression (Class II, 1 clearances)
• QRV — Setmelanotide Eligibility Gene Variant Detection System (Class II, 1 clearances)
• QRX — Continuous Glucose Monitor Informed Insulin Dose Calculator (Class II, 5 clearances)
• QUM — Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test (Class II)
• QWZ — Prognostic Test For Assessment Of Chronic Kidney Disease Progression (Class II, 1 clearances)
• QXC — Diabetes Digital Therapeutic Device (Class II, 1 clearances)
• QZG — Menstrual Blood Collection Device (Class II)
• SAF — Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (Class II, 3 clearances)
• SBA — Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (Class II, 2 clearances)
• SBH — Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter (Class II, 1 clearances)
• SCE — Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule (Not classified)
• SCF — Ldt, Unmet Need Within An Integrated Healthcare System (Not classified)
• SCG — Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule (Not classified)
• SCH — Ldt, Approved By Nys Clep (Not classified)
• SCI — Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule (Not classified)
• SCJ — Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule (Not classified)
• SFI — Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System (Class III)
• SFO — Electrode Measurement, Drain Effluent Ph (Class II, 1 clearances)
• SFU — Glucose Range Monitoring System (Class II, 1 clearances)
• SHB — Creatinine Test System For At Home Prescription Use (Class II, 1 clearances)
• SIB — Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic (Not classified)
• SIC — Tempo Pilot Ckm: Cardio-Kidney-Metabolic (Not classified)
• SID — Tempo Pilot Msk: Musculoskeletal (Not classified)
• SIE — Tempo Pilot Bh: Behavioral Health (Not classified)
• SIO — Test For Esophageal Varices (Class III)