Hematology device product codes

281 FDA product codes. All panels.

• BSA — Warmer, Blood, Electromagnetic Radiation (Class III)
• BSB — Warmer, Blood, Non-Electromagnetic Radiation (Class II, 14 clearances)
• DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II, 57 clearances)
• DAR — Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control (Class II)
• DAT — Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control (Class II, 2 clearances)
• DAX — Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control (Class II)
• DAZ — Fibrinogen And Split Products, Antigen, Antiserum, Control (Class II)
• DBT — Factor Xiii A, S, Antigen, Antiserum, Control (Class I, 1 clearances)
• DDE — Carbonic Anhydrase C, Antigen, Antiserum, Control (Class I, 3 clearances)
• DDF — Prothrombin, Antigen, Antiserum, Control (Class I, 2 clearances)
• DDH — Carbonic Anhydrase B, Antigen, Antiserum, Control (Class I)
• DDQ — Antigen, Antiserum, Control, Antithrombin Iii (Class II, 4 clearances)
• DDX — Plasminogen, Antigen, Antiserum, Control (Class I, 10 clearances)
• DGB — Seminal Fluid, Antigen, Antiserum, Control (Class I, 1 clearances)
• DGQ — Whole Blood Plasma, Antigen, Antiserum, Control (Class I, 1 clearances)
• DGR — Whole Human Serum, Antigen, Antiserum, Control (Class I, 5 clearances)
• GFK — Fibrinogen Determination Standards And Controls (Class II, 1 clearances)
• GFO — Activated Partial Thromboplastin (Class II, 52 clearances)
• GFS — Standards And Controls, Hemoglobin, Normal And Abnormal (Class II, 1 clearances)
• GFT — Protamine Sulphate (Class II, 2 clearances)
• GFX — Fibrinogen Standard (Class II, 3 clearances)
• GGC — Control, Plasma, Abnormal (Class II, 40 clearances)
• GGF — Acid Hematin (Class II)
• GGG — Guaiac Reagent (Class II, 1 clearances)
• GGJ — Fluid, Diluting, White-Cell (Class I, 1 clearances)
• GGK — Products, Red-Cell Lysing Products (Class I, 29 clearances)
• GGL — Control, White-Cell (Class II, 8 clearances)
• GGM — Control, Hemoglobin (Class II, 15 clearances)
• GGN — Plasma, Coagulation Control (Class II, 99 clearances)
• GGO — Reagent, Thromboplastin And Control (Class II, 1 clearances)
• GGP — Test, Qualitative And Quantitative Factor Deficiency (Class II, 190 clearances)
• GGQ — Test, Prothrombin Consumption (Class II, 2 clearances)
• GGT — Assay, Erythropoietin (Class II, 20 clearances)
• GGW — Test, Time, Partial Thromboplastin (Class II, 32 clearances)
• GGX — Pipette, Sahli (Class I, 2 clearances)
• GGY — Pipette, Diluting (Class I)
• GGZ — Oxyhemoglobin (Class II, 2 clearances)
• GHA — Hemoglobin, Alkali Resistant (Class II)
• GHC — Tube, Sedimentation Rate (Class I, 1 clearances)
• GHD — Test, Leukocyte Alkaline Phosphatase (Class I, 4 clearances)
• GHH — Fibrin Split Products (Class II, 28 clearances)
• GHK — Centrifuge, Microsedimentation (Class I)
• GHM — Test, Sickle Cell (Class II, 18 clearances)
• GHO — Hemocytometer (Class I, 2 clearances)
• GHQ — Stain, Fetal Hemoglobin (Class II, 2 clearances)
• GHR — Reagent, Platelet Aggregation (Class II, 11 clearances)
• GHS — Assay, Carboxyhemoglobin (Class II, 5 clearances)
• GHY — Hematocrit, Tube, Rack, Sealer, Holder (Class II, 2 clearances)
• GIE — Fibrometer (Class II, 2 clearances)
• GIF — Diluent, Blood Cell (Class I, 38 clearances)
• GIG — Hemoglobinometer (Class II, 3 clearances)
• GII — Glutathione, Red-Cell (Class II)
• GIL — Plasma, Fibrinogen Control (Class II, 8 clearances)
• GIO — Tube, Collection, Capillary Blood (Class I, 22 clearances)
• GIQ — Hemoglobin S (Class II, 3 clearances)
• GIR — Reagent, Russel Viper Venom (Class I, 16 clearances)
• GIS — Test, Fibrinogen (Class II, 13 clearances)
• GIT — Reagent & Control, Partial Thromboplastin Time (Class II, 4 clearances)
• GIZ — Plasma, Control, Normal (Class II, 20 clearances)
• GJA — Test, Thrombin Time (Class II, 20 clearances)
• GJB — Thrombin (Class II, 1 clearances)
• GJC — Assay, Sulfhemoglobin (Class II)
• GJG — Pipette, Quantitative, Hematology (Class I, 4 clearances)
• GJH — Stain, Reticulocyte (Class I, 1 clearances)
• GJJ — Stains, Heinz Body (Class I)
• GJL — Romanowsky Stains (Class I, 1 clearances)
• GJN — Fluid, Diluting, Red-Cell (Class I)
• GJP — Control, Platelet (Class II, 4 clearances)
• GJR — Control, Red-Cell (Class II, 5 clearances)
• GJS — Test, Time, Prothrombin (Class II, 127 clearances)
• GJT — Plasma, Coagulation Factor Deficient (Class II, 79 clearances)
• GJW — Pipette, Pasteur (Class I, 4 clearances)
• GJZ — Cyanomethemoglobin Reagent And Standard Solution (Class II, 2 clearances)
• GKA — Abnormal Hemoglobin Quantitation (Class II, 23 clearances)
• GKB — Device, Automated Sedimentation Rate (Class I, 2 clearances)
• GKE — Osmotic Fragility Testing (Class I)
• GKF — Instrument, Hematocrit, Automated (Class II, 15 clearances)
• GKG — Centrifuge, Hematocrit (Class II, 11 clearances)
• GKH — Apparatus, Automated Blood Cell Diluting (Class I, 14 clearances)
• GKJ — Spinner, Slide, Automated (Class I, 6 clearances)
• GKK — Cyanomethemoglobin (Class II, 7 clearances)
• GKL — Counter, Cell, Automated (Particle Counter) (Class II, 130 clearances)
• GKM — Hand-Tally, Differential (Class I, 4 clearances)
• GKN — Timer, Clot, Automated (Class II, 3 clearances)
• GKP — Instrument, Coagulation, Automated (Class II, 49 clearances)
• GKQ — Test, Thromboplastin Generation (Class I, 1 clearances)
• GKR — System, Hemoglobin, Automated (Class II, 39 clearances)
• GKT — Separator, Automated, Blood Cell, Diagnostic (Class II, 10 clearances)
• GKW — Aggregometer, Platelet, Thrombokinetogram (Class II)
• GKX — Instrument, Automated Platelet Counting (Class II, 2 clearances)
• GKZ — Counter, Differential Cell (Class II, 379 clearances)
• GLG — Platelet Counting, Manual (Class I, 3 clearances)
• GLK — Control, Hematocrit (Class II, 7 clearances)
• GLQ — Mixture, Control, White-Cell And Red-Cell Indices (Class II, 10 clearances)
• GLY — Oximeter To Measure Hemoglobin (Class II, 5 clearances)
• IAZ — Heparin (Class I)
• IFO — Solution, Newcomer'S (Class I)
• IFS — Solution, Helly (Class I)
• IGK — Solution, Clarke'S (Class I)
• IJZ — Oil, Clearing (Class I, 1 clearances)
• JBB — Solubility, Hemoglobin, Abnormal (Class II, 2 clearances)
• JBD — System, Analysis, Electrophoretic Hemoglobin (Class II, 26 clearances)
• JBE — Cell Enzymes (Erythrocytic And Leukocytic) (Class II, 1 clearances)
• JBF — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening (Class II, 5 clearances)
• JBG — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot (Class II)
• JBH — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod (Class II)
• JBI — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition (Class II)
• JBJ — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction (Class II)
• JBK — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic (Class II)
• JBL — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative (Class II, 2 clearances)
• JBM — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis (Class II)
• JBN — Fibrin Monomer Paracoagulation (Class II, 2 clearances)
• JBO — Test, Euglobulin Lysis (Class II, 1 clearances)
• JBP — Activated Whole Blood Clotting Time (Class II, 24 clearances)
• JBQ — Antithrombin Iii Quantitation (Class II, 56 clearances)
• JBR — Test, Heparin Neutralization (Class II, 3 clearances)
• JBT — Timer, Coagulation (Class II)
• JBW — Red-Cell Indices, Measured (Class II)
• JBX — Aggregrometer, Platelet (Class II, 12 clearances)
• JBY — Aggregometer, Platelet, Photo-Optical Scanning (Class II, 2 clearances)
• JBZ — Study, Platelet Adhesive (Class II, 3 clearances)
• JCA — Device, Bleeding Time (Class II, 7 clearances)
• JCF — Lymphocyte Separation Medium (Class I, 12 clearances)
• JCG — Fluid, Diluting, Manual Cell (Class I, 1 clearances)
• JCJ — Alkaline Phosphatase (Class I)
• JCM — Control, Hemoglobin, Abnormal (Class II, 12 clearances)
• JCN — Control, Cell Counter, Normal And Abnormal (Class II, 12 clearances)
• JCO — Bothrops Atrox Reagent (Class II, 7 clearances)
• JIO — Blood, Occult, Colorimetric, In Urine (Class II, 11 clearances)
• JIP — Blood, Occult, Enzymatic Method, In Urine (Class II)
• JLM — Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase (Class II, 1 clearances)
• JMB — Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase (Class II, 1 clearances)
• JMC — Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase (Class II)
• JMH — Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase (Class II)
• JOX — Analyzer, Heparin, Automated (Class II, 15 clearances)
• JOY — Device, Automated Cell-Locating (Class II, 35 clearances)
• JOZ — System, Automated Platelet Aggregation (Class II, 38 clearances)
• JPA — System, Multipurpose For In Vitro Coagulation Studies (Class II, 181 clearances)
• JPB — Hemoglobin M (Class II)
• JPC — Hemoglobin F Quantitation (Class II, 1 clearances)
• JPD — Hemoglobin A2 Quantitation (Class II, 13 clearances)
• JPE — Antithrombin Iii, Two Stage Clotting Time Assay (Class II, 1 clearances)
• JPF — Prothrombin-Proconvertin And Thrombotest (Class II)
• JPH — Test, Erythrocyte Sedimentation Rate (Class I, 7 clearances)
• JPI — Device, Hematocrit Measuring (Class II, 15 clearances)
• JPJ — Red-Cell Indices, Calculated (Class II, 3 clearances)
• JPK — Mixture, Hematology Quality Control (Class II, 192 clearances)
• JWO — Device, Blood Volume Measuring (Class II, 2 clearances)
• JWR — Atp Release (Luminescence) (Class I)
• KFF — Assay, Heparin (Class II, 46 clearances)
• KHE — Reagent, Occult Blood (Class II, 97 clearances)
• KHF — Adenine Nucleotide Quantitation (Class I)
• KHG — Whole Blood Hemoglobin Determination (Class II, 39 clearances)
• KQE — Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase (Class II, 1 clearances)
• KQF — Assay, Glutathione Reductase (Class II)
• KQG — Instrument, Coagulation (Class II, 14 clearances)
• KQH — Red-Cell Indices (Class II, 1 clearances)
• KQI — Assay, Fetal Hemoglobin (Class II, 4 clearances)
• KQJ — System, Fibrinogen Determination (Class II, 28 clearances)
• KRX — Calibrator For Cell Indices (Class II, 16 clearances)
• KRY — Calibrator For Platelet Counting (Class II, 8 clearances)
• KRZ — Calibrator For Hemoglobin And Hematocrit Measurement (Class II, 25 clearances)
• KSA — Calibrator For Red-Cell And White-Cell Counting (Class II, 8 clearances)
• KSB — Set, Transfer (Blood/Plasma) (Class II, 6 clearances)
• KSD — Device, Heat-Sealing (Class I, 1 clearances)
• KSE — Refrigerator, Freezer, Blood Storage (Class II, 4 clearances)
• KSF — Kit, Quality Control For Blood Banking Reagents (Class II, 12 clearances)
• KSG — Media, Potentiating For In Vitro Diagnostic Use (Class II, 13 clearances)
• KSH — Chamber, Environmental For The Storage Of Platelet Concentrate (Class II)
• KSI — Lectins And Protectins (Class II, 4 clearances)
• KSJ — System, Identification, Hepatitis B Antigen (Class III)
• KSK — Solution, Stabilized Enzyme (Class II, 5 clearances)
• KSL — Solution, Copper Sulfate For Specific Gravity Determinations (Class I, 2 clearances)
• KSM — System, Test, Combs, Automated (Class II)
• KSN — Centrifuge, Cell-Washing, Automated For Immuno-Hematology (Class II, 1 clearances)
• KSO — Centrifuge, Blood-Bank For In Vitro Diagnostic Use (Class I, 1 clearances)
• KSP — Apparatus, Cell-Freezing And Reagents (Class I, 1 clearances)
• KSQ — Device, Blood Mixing And Blood Weighing (Class I, 8 clearances)
• KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components (Class II, 16 clearances)
• KSS — Supplies, Blood-Bank (Class I, 6 clearances)
• KST — System, Blood Collection, Vacuum-Assisted, Manual (Class I)
• KSW — System, Processing For Frozen Blood (Class II, 1 clearances)
• KSX — Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use (Class II, 8 clearances)
• KSY — Boxes, View, Blood Grouping (Class I, 1 clearances)
• KSZ — System, Test, Automated Blood Grouping And Antibody (Class II, 4 clearances)
• KTK — Reagent, Immunoassay, Carbonic Anhydrase B And C (Class I)
• KZL — Device, Warming. Blood And Plasma (Class II, 4 clearances)
• LCO — Platelet Factor 4 Radioimmunoassay (Class II, 13 clearances)
• LCP — Assay, Glycosylated Hemoglobin (Class II, 249 clearances)
• LGL — Assay, Bart'S, Hemoglobin (Class II, 2 clearances)
• LGO — Test, Leukocyte Typing (Class I, 5 clearances)
• LGP — Assay, Alpha-2-Antiplasmin (Class II, 5 clearances)
• LIM — Test, Screening, For D Positive Fetal Rbc'S (Class II, 2 clearances)
• LJX — Test, Urine Leukocyte (Class I, 7 clearances)
• LKM — Counter, Urine Particle (Class II, 15 clearances)
• LKZ — Red-Cell Count By Photometry (Class II, 2 clearances)
• LLG — Kit, Igg, Platelet Associated (Class II, 2 clearances)
• LOQ — Device, General Purpose, Hematology (Class II, 1 clearances)
• MAM — Dna-Probe, B And T Lymphocyte (Class II, 1 clearances)
• MIF — Prothrombin Fragment 1.2 (Class II, 6 clearances)
• MLL — Hemoglobin C (Abnormal Hemoglobin Variant) (Class II, 1 clearances)
• MMH — Blood Establishment Computer Software And Accessories (Class II)
• MTH — Tray, Leukocyte Typing (Not classified)
• MTK — Kit, Sample Collection, Hiv (Class III)
• MTL — Monitor,Test,Hiv-1 (Class III)
• MTN — Test, Syphilis, Treponemal (Not classified)
• MTO — Software, Management, Microplate Assay (Not classified)
• MTP — Antibody To Htlv-1, Elisa (Class III)
• MTQ — Software, Blood Virus Applications (Not classified)
• MTR — Progenitor Cell Enumeration (Class II)
• MTS — Vials, Challenge, Endotoxin (Not classified)
• MVS — Kit, Typing, Hla-Dqb (Class II, 1 clearances)
• MVU — Reagents, Specific, Analyte (Class I)
• MVW — Kit, Western Blot, Hiv-1 (Not classified)
• MVX — Antibody, Monoclonal Blocking, Hiv-1 (Not classified)
• MVY — Monoclonal, Hiv-1 (Not classified)
• MVZ — System, Test, Home, Hiv-1 (Class III)
• MWB — Kit, Test, Saliva, Hiv-1&2 (Class III)
• MWO — Reagent, Blood Bank, Quality Control (Not classified)
• MYJ — Device, Mixing And Weighing, Semi-Automated (Class II)
• MYK — Kit, Cord Blood Collection (Not classified)
• MYP — Test, Platelet Antibody (Class II)
• MYS — Device, Ahf, Automated Cryoprecipitation (Not classified)
• MYW — Irradiation, Blood Indicators (Not classified)
• MYX — System, Blood Collection, Vacuum-Assisted, Automated (Class I)
• MYY — Separator, Semi-Automated, Blood Component (Class I)
• MZG — Test, Residual, Wbc In Leukoreduced Blood (Class II)
• MZH — Test, Quantitative, For Hla, Non-Diagnostic (Not classified)
• MZI — Test, Qualitative, For Hla, Non-Diagnostic (Unclassified)
• MZK — System, Separation, Hematopoietic Stem Cell (Class III)
• MZM — Fibrin Sealant Preparation Device (Class II)
• NDV — Test, Ecarin Clotting Time (Ect) (HDE)
• NOZ — Assay, 1,5-Anhydroglucitol (15ag) (Class II, 2 clearances)
• NRF — Material, Quality Control, Semen Analysis (Class II, 3 clearances)
• NRS — Control Material, Blood Circulating Epithelial Cancer Cell (Class II, 1 clearances)
• NVG — Tissue Culture, Accessories, Dental (Class I)
• OAO — Cord Blood Processing System And Storage Container (Class II)
• OBW — 11-Dehydro Thromboxane B2 Kit, Urinary (Class II, 1 clearances)
• ODV — Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System (Class II, 1 clearances)
• OMM — Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr (Class II, 2 clearances)
• OOF — Cryogenic Cord Blood Storage Container (Class II)
• OOX — Automated Occult Blood Analyzer (Class II, 6 clearances)
• OQX — Self-Contained Blood Grouping (Class II)
• ORG — Platelet And Plasma Separator For Bone Graft Handling (Class II)
• OSL — Control, Fecal Occult Blood (Class II, 1 clearances)
• OTQ — Research Use Only/Hematology Devices (Not classified)
• OVG — Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) (HDE)
• OYE — Flow Cytometric Reagents And Accessories. (Class II, 8 clearances)
• PBA — Ecarin Clotting Time (HDE)
• PBC — Manual Blood Grouping And Antibody Test Systems (Class II)
• PCZ — Investigational Use Only - Immunology (Not classified)
• PDC — Investigational Use Only - Hematology (Not classified)
• PEP — Molecular Erythrocyte Typing Test (Class III)
• PHY — Sparse Sample Pk Profile And Dosing Software (Class II)
• PJF — Illuminator System For Blood Products (Class III)
• PKG — Bone Marrow Processing Device To Support Hematopoietic Reconstitution (Class II)
• PMG — Automated Multicolor Fluorescent Imaging Cytometric Analysis System (Class II, 1 clearances)
• PMQ — Peripheral Blood Processing Device For Wound Management (Class II)
• POV — Semen Analysis Device (Class II, 28 clearances)
• PWD — Flow Cytometric Test System For Hematopoietic Neoplasms (Class II, 2 clearances)
• PZT — Peripheral Blood Processing Device For Osteoarthritis (Not classified)
• PZU — Bone Marrow Processing Device For Clinical Use (Not classified)
• PZV — Peripheral Blood Processing Device For Clinical Use (Not classified)
• QBG — Assay, Oral Direct Thrombin Inhibitor (Not classified)
• QBV — Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate (Class I, 2 clearances)
• QCZ — Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator (Class III)
• QFR — Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (Class II, 8 clearances)
• QGU — Hemoglobin For Donor Testing (Class II)
• QHR — Blood Grouping Reagent (Unclassified)
• QHS — Anti-Human Globulin (Unclassified)
• QHT — Reagent Red Blood Cells (Unclassified)
• QLU — Anti-Factor Xa Activity Test System, Apixaban (Class II, 3 clearances)
• QPW — Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube (Not classified)
• QTY — Von Willebrand Factor Assay (Class II, 1 clearances)
• QWY — Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator (Class III)
• QYC — Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions (Class II)
• QZV — Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury (Class III)
• SAC — Adamts13 Activity Test System (Class II, 1 clearances)
• SAL — Device, Automated Cell Locating, Bone Marrow (Class II, 1 clearances)
• SCK — Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd (Not classified)
• SES — Non-Factor Replacement Product Test System (Class II, 1 clearances)