Pathology device product codes

323 FDA product codes. All panels.

• DAA — Igg, Peroxidase, Antigen, Antiserum, Control (Class II, 5 clearances)
• DEP — Lambda, Peroxidase, Antigen, Antiserum, Control (Class II, 1 clearances)
• DEY — Igm, Peroxidase, Antigen, Antiserum, Control (Class II, 3 clearances)
• DFD — Kappa, Peroxidase, Antigen, Antiserum, Control (Class II, 3 clearances)
• DGH — Igd, Peroxidase, Antigen, Antiserum, Control (Class II, 1 clearances)
• DGO — Ige, Peroxidase, Antigen, Antiserum, Control (Class II, 15 clearances)
• DHF — D/Km-1, Antigen, Antiserum, Control (Class I, 1 clearances)
• GGH — Iron Stains (Class I, 1 clearances)
• GHZ — Solution, Gugol Blue (Class I)
• GIA — Test, Leukocyte Peroxidase (Class I, 3 clearances)
• HYB — Eosin Y (Class I, 10 clearances)
• HYC — Fast Green (Class I, 1 clearances)
• HYD — Fast Red Salt B (Class I, 1 clearances)
• HYE — Solution, Fontanna Silver (Class I)
• HYF — Giemsa Stain (Class I, 4 clearances)
• HYG — Glenner'S Stain (Class I, 1 clearances)
• HYH — Gold Chloride (Class I)
• HYI — Iodine, Grams (Class I, 6 clearances)
• HYJ — Hematoxylin (Class I, 14 clearances)
• HYK — Hematoxylin Harris'S (Class I, 7 clearances)
• HYL — Hematoxylin Mayer'S (Class I)
• HYO — Hematoxylin Weigert'S (Class I, 1 clearances)
• HYQ — Iron Chloride-Weigert (Class I)
• HYR — Leuco-Patent Blue (Class I)
• HYS — Light Green (Class I, 1 clearances)
• HYT — Luxol Fast Blue (Class I)
• HYW — Stain, Trichrome, Mallory'S (Class I, 2 clearances)
• HYY — Metanil Yellow (Class I)
• HYZ — Methenamine Silver (Class I)
• HZA — Methyl Green (Class I, 2 clearances)
• HZC — Mucicarmine (Class I, 2 clearances)
• HZD — Muller'S Colloidal Iron (Class I)
• HZE — Nile Blue (Class I)
• HZF — Nuclear Fast Red (Class I)
• HZG — Oil Red O (Class I, 1 clearances)
• HZH — Orange G (Class I, 4 clearances)
• HZI — Acid, Osmic (Class I)
• HZJ — Stain, Papanicolau (Class I, 15 clearances)
• HZL — Phloxine B (Class I, 1 clearances)
• HZM — Hematoxylin, Acid, Phosphotungstic (Class I)
• HZN — Picro Methyl Blue (Class I)
• HZO — Stain, Ponceau (Class I, 1 clearances)
• HZP — Pyronin (Class I)
• HZQ — Red-Violet Lb (Class I)
• HZR — Resorcin Fuchsin (Class I)
• HZS — Safranin (Class I, 1 clearances)
• HZT — Reagent, Schiff (Class I, 5 clearances)
• HZX — Silver Nitrate (Class I)
• HZY — Sirius Red (Class I)
• HZZ — Sudan Black B (Class I, 2 clearances)
• IAA — Titan Yellow (Class I)
• IAB — Toluidine Blue (Class I, 1 clearances)
• IAC — Van Gieson'S Stain (Class I, 1 clearances)
• IAD — Van Gieson'S Picro-Fuchsin (Class I)
• IAE — Hematoxylin, Iron, Weigert'S (Class I, 1 clearances)
• IAF — Wright'S Stain (Class I, 33 clearances)
• IAL — Iodine (Tincture) (Class I)
• IAM — Solution, Lugol'S (Class I)
• IAT — Syrup, Gum, Apathy'S (Class I)
• IAW — Collodion (Class I)
• IAY — Colchicine (Class I)
• IBA — Streptolysin O (Class I)
• IBC — Diastase (Class I)
• IBD — Hyaluronidase (Class I)
• IBE — Neuramininase (Sialidase) (Class I)
• IBF — Papain (Class I)
• IBG — Trypsin (Class I, 2 clearances)
• IBJ — Light, Microscope (Class I, 9 clearances)
• IBK — Microscope, Fluorescence/U.V. (Class I, 1 clearances)
• IBL — Microscope, Inverted Stage, Tissue Culture (Class I)
• IBM — Microscope, Phase Contrast (Class I, 1 clearances)
• ICC — Eosin B (Class I, 1 clearances)
• ICD — Darrow Red (Class I)
• ICF — Crystal Violet For Histology (Class I, 5 clearances)
• ICG — Cresyl Violet Acetate (Class I)
• ICH — Congo Red (Class I, 1 clearances)
• ICI — Hematoxylin, Chrome Alum (Class I)
• ICJ — Carbol Night Blue (Class I, 1 clearances)
• ICL — Carbol Fuchsin (Class I, 4 clearances)
• ICM — Brilliant Yellow (Class I)
• ICN — Biebrich Scarlet (Class I, 2 clearances)
• ICO — Best'S Carmine (Class I)
• ICQ — Azure A (Class I)
• ICR — Azocarmine B (Class I)
• ICS — Azocarmine G (Class I)
• ICT — Azan Counterstain (Class I)
• ICX — Aniline (Class I, 1 clearances)
• ICY — Acid, Aniline, Fuchsin (Class I)
• ICZ — Ammoniacal Silver Hydroxide Silver Nitrate (Class I)
• IDA — Alcian Blue (Class I, 2 clearances)
• IDB — Aldehyde Fuchsin (Class I)
• IDC — Acridine Orange (Class I, 4 clearances)
• IDD — Alizarin Red (Class I)
• IDE — Acid, Hematein (Class I)
• IDF — Acid, Fuchsin (Class I, 1 clearances)
• IDL — Microtome, Accessories (Class I, 5 clearances)
• IDM — Microtome, Ultra (Class I, 1 clearances)
• IDN — Microtome, Freezing Attachment (Class I)
• IDO — Microtome, Rotary (Class I, 5 clearances)
• IDP — Microtome, Cryostat (Class I, 1 clearances)
• IDQ — Infiltrator (Class I)
• IDR — Ovens, Paraffin (Class I)
• IDS — Melting Pot, Paraffin (Class I, 1 clearances)
• IDT — Apparatus, Melting Point, Paraffin (Class I)
• IDW — Dispensers, Paraffin (Class I, 1 clearances)
• IDX — Sieves, Tissue (Class I)
• IDY — Bath, Flotation, Tissue (Class I)
• IDZ — Cassettes, Tissue (Class I, 5 clearances)
• IEG — Table, Slide Warming (Class I, 1 clearances)
• IEH — Lamps, Slide Warming (Class I)
• IEO — Processor, Tissue, Automated (Class I, 12 clearances)
• IER — Polyethylene Glycol (Carbowax) (Class I, 1 clearances)
• IEX — Gelatin (Class I)
• IEZ — Celloidin (Class I)
• IFB — Cytocentrifuge (Class I, 3 clearances)
• IFF — Solution, Decalcifier, Electrolytic (Class I)
• IFH — Solution, Zenker'S (Class I, 2 clearances)
• IFI — Sprays, Synthetic, Smear (Class I, 1 clearances)
• IFJ — Fixative, Richardson Glycol (Class I)
• IFL — Polyethylene Glycol Preservative (Class I)
• IFN — Solution, Orth'S (Class I)
• IFP — Formalin, Neutral Buffered (Class I, 15 clearances)
• IFQ — Formulations, Mercuric Chloride For Tissue (Class I, 2 clearances)
• IFT — Glutaraldehyde (Class I, 1 clearances)
• IFY — Gelatin-Formalin (Class I)
• IFZ — Gelatin For Specimen Adhesion (Class I, 1 clearances)
• IGB — Solution, Formalin-Sodium Acetate (Class I, 1 clearances)
• IGC — Formalin-Saline (Class I, 2 clearances)
• IGD — Solution, Formol Calcium (Class I)
• IGE — Solution, Formalin Ammonium Bromide (Class I, 2 clearances)
• IGF — Solution, Formalin-Alcohol-Acetic Acid (Class I, 1 clearances)
• IGG — Formaldehyde (Formalin, Formol) (Class I, 7 clearances)
• IGM — Solution, Carnoy'S (Class I, 3 clearances)
• IGN — Fluid, Bouin'S (Class I, 2 clearances)
• IHJ — Blender, Sputum (Class I)
• JCB — Detergent (Class I)
• JCC — Ph Buffer (Class I, 7 clearances)
• JCE — Solution, Isotonic (Class I, 7 clearances)
• JCH — Esterase (Class I)
• JCI — Acid Phosphatase, Cytochemical (Class I)
• KDT — Container, Specimen Mailer And Storage, Sterile (Class I, 12 clearances)
• KDW — Container, Specimen Mailer And Storage, Temperature Controlled, Sterile (Class I, 4 clearances)
• KDX — Solution, Decalcifier, Acid Containing (Class I, 8 clearances)
• KDY — Agent, Chelating For Decalcification (Class I)
• KDZ — Device, Decalcifier, Electrolytic (Class I)
• KEE — Osmium Tetroxide (Class I)
• KEG — Lamps, Microscope (Class I)
• KEH — Micrometers, Microscope (Class I)
• KEI — Condensers, Microscope (Class I)
• KEJ — Stages, Microscope (Class I, 1 clearances)
• KEL — Adhesive, Albumin-Based (Class I, 2 clearances)
• KEM — Agent, Clearing (Class I, 15 clearances)
• KEO — Formulations, Paraffin, All (Class I, 11 clearances)
• KEP — Media, Mounting, Oil Soluble (Class I, 3 clearances)
• KEQ — Media, Mounting, Water Soluble (Class I, 7 clearances)
• KER — Container, Embedding (Class I, 5 clearances)
• KES — Coverslips, Microscope Slide (Class I, 3 clearances)
• KET — Filters, Cell Collection, Tissue Processing (Class I, 5 clearances)
• KEW — Slides, Microscope (Class I, 8 clearances)
• KEY — Stainer, Tissue, Automated (Class I, 1 clearances)
• KFC — Methylene Blue, Tissue Stain (Class I, 7 clearances)
• KFD — Aniline Blue (Class I, 1 clearances)
• KFE — Neutral Red (Class I, 1 clearances)
• KFL — Microtome, Sliding (Class I)
• KIM — Device For Sealing Microsections (Class I, 1 clearances)
• KIN — Slide Stainer, Contact Type (Class I, 1 clearances)
• KIO — Slide Stainer, Immersion Type (Class I, 1 clearances)
• KIP — Formulations, Balanced Salt Solutions (Class I, 17 clearances)
• KIQ — Kit, Culture, Chromosome (Class I, 1 clearances)
• KIR — Cells, Animal And Human, Cultured (Class I, 170 clearances)
• KIS — Sera, Animal And Human (Class I, 45 clearances)
• KIT — Media And Components, Synthetic Cell And Tissue Culture (Class I, 367 clearances)
• KIW — Kit, Mycoplasma Detection (Class I, 2 clearances)
• KIX — Media, Mycoplasma Detection (Class I)
• KIY — Chamber, Slide Culture (Class I, 1 clearances)
• KIZ — Dish, Tissue Culture (Class I, 8 clearances)
• KJA — Flask, Tissue Culture (Class I, 13 clearances)
• KJB — Apparatus, Roller (Class I, 3 clearances)
• KJC — Bottle, Roller, Tissue Culture (Class I, 3 clearances)
• KJD — Spinner, Flask (Class I)
• KJE — Spinner System, Cell Culture (Class I)
• KJF — System, Suspension, Cell Culture (Class I, 4 clearances)
• KJG — Tube, Tissue Culture (Class I, 1 clearances)
• KJH — Apparatus, Perfusion (Class I, 3 clearances)
• KJK — Auramine O (Class I, 2 clearances)
• KJL — Azure C (Class I)
• KJM — Bismarck Brown Y (Class I)
• KJN — Brilliant Cresyl Blue (Class I, 1 clearances)
• KJO — Brilliant Green (Class I)
• KJP — Carmine (Class I)
• KJQ — Chlorazol Black E (Class I)
• KJR — Erythrosin B (Class I, 3 clearances)
• KJS — Ethyl Eosin (Class I)
• KJT — Indigocarmine (Class I)
• KJW — Janus Green B (Class I)
• KJX — Jenner Stain (Class I, 1 clearances)
• KJY — Malachite Green (Class I, 1 clearances)
• KJZ — Martius Yellow (Class I)
• KKA — Methyl Orange (Class I)
• KKB — Methyl Violet 2b (Class I)
• KKC — Methylene Violet (Class I)
• KKD — Nigrosin (Class I)
• KKE — Orange Ii (Class I)
• KKF — Orcein (Class I)
• KKG — Protargol S (Class I)
• KKH — Tablet, Resazurin (Class I)
• KKI — Rose Bengal (Class I)
• KKJ — Sudan Iii (Class I, 1 clearances)
• KKK — Sudan Iv (Class I, 1 clearances)
• KKL — Thionin (Class I)
• KKM — Methylene Blue Thiocyanate (Class I)
• KKP — Solution, Silver Carbonate (Class I)
• KKQ — Sodium Periodate (Class I)
• KKR — Potassium Periodate (Class I)
• KKS — Acid, Periodic (Class I)
• KKT — Hematoxylin, Ehrlich'S (Class I)
• KKW — Basic Fuchsin (Class I)
• KPA — Slide Stainer, Automated (Class I, 21 clearances)
• KPB — Media And Components, Mycoplasma Detection (Class I, 4 clearances)
• KQC — Stains, Hematology (Class I, 9 clearances)
• LDW — Fixative, Acid Containing (Class I, 4 clearances)
• LDX — Fixative, Metallic Containing (Class I, 1 clearances)
• LDY — Fixative, Formalin-Containing (Class I, 1 clearances)
• LDZ — Fixative, Alcohol Containing (Class I, 8 clearances)
• LEA — Preservative, Cytological (Class I, 4 clearances)
• LEB — Mounting Media (Class I, 5 clearances)
• LEC — Grinder, Tissue (Class I)
• LED — Stains, Chemical Solution (Class I, 16 clearances)
• LEE — Stains, Dye Solution (Class I, 1 clearances)
• LEF — Stains, Dye Powder (Class I, 1 clearances)
• LGY — Trypan Blue (Class I, 1 clearances)
• LIJ — Peroxidase Anti-Peroxidase Immunohistochemical Stain (Class I, 2 clearances)
• LNJ — Analyzer, Chromosome, Automated (Class II, 11 clearances)
• LYE — Cytokeratins (Class II, 2 clearances)
• MAO — Dna-Probe, Human Chromosome (Unclassified)
• MJI — Specimen/Tissue, Identification Orientation (Class I)
• MKQ — Processor, Cervical Cytology Slide, Automated (Class III)
• MNM — Reader, Cervical Cytology Slide, Automated (Class III)
• MTI — Kit, Cell Screening, Fetal (Not classified)
• MVC — System, Test, Her-2/Neu, Ihc (Class III)
• MVD — System, Test, Her-2/Neu, Nucleic Acid Or Serum (Class III)
• MXZ — Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II, 13 clearances)
• MYA — Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II, 12 clearances)
• NBK — System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer (Class II, 1 clearances)
• NJT — Immunohistochemistry Reagents And Kits (Class I)
• NJW — Control Material, Her-2/Neu, Immunohistochemistry (Class II, 2 clearances)
• NKF — Immunohistochemistry Antibody Assay, C-Kit (Class III)
• NNK — Container, Specimen Mailer And Storage, Non-Sterile (Class I)
• NNL — Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile (Class I)
• NOT — Microscope, Automated, Image Analysis, Operator Intervention (Class II, 12 clearances)
• NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr (Class II, 6 clearances)
• NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II, 5 clearances)
• NQF — Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor (Class III)
• NQI — System, Immunomagnetic, Circulating Cancer Cell, Enumeration (Class II, 13 clearances)
• NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity (Class II, 15 clearances)
• NSD — Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence (Class III)
• NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays (Class II, 8 clearances)
• NTR — Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells (Class I, 1 clearances)
• NTW — System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test (Class II, 2 clearances)
• NUA — System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (Class II, 12 clearances)
• NXG — Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion (Class III)
• NYI — Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer (Class II, 10 clearances)
• OEO — Automated Digital Image Manual Interpretation Microscope (Class II, 6 clearances)
• OQS — Laboratory Developed Test (Not classified)
• OTU — Research Use Only/Pathology (Not classified)
• OVQ — Chronic Lymphocytic Leukemia Fish Probe Kit (Class II, 2 clearances)
• OWD — Somatic Gene Mutation Detection System (Class III)
• OWE — Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement (Class III)
• OWK — Early Growth Response 1 (Egr) Fish Probe Kit (Class II, 1 clearances)
• OWM — Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers (Class II, 1 clearances)
• OXP — Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment (Class II, 1 clearances)
• OYU — Dna-Probe Kit, Human Chromosome (Class II, 3 clearances)
• OYV — Inherited Nucleotide Repeat Disorder Dna Test (Class II, 1 clearances)
• OYX — Bcr/Abl1 Monitoring Test (Class II, 5 clearances)
• OZF — Tissue Rna Preservative For Collection, Storage, And Transportation (Class II, 1 clearances)
• PAN — Braf Mutation Kit (Not classified)
• PDD — Investigational Use Only - Pathology (Not classified)
• PDO — Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization (Class II, 1 clearances)
• PFG — Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders (Class II, 1 clearances)
• PFK — Quality Control For Molecular Immunohematology Tests (Class II)
• PFR — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection (Class II, 1 clearances)
• PFS — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection (Class II, 1 clearances)
• PFU — Tissue Processing Kit (Not classified)
• PFX — System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection (Class II, 2 clearances)
• PHJ — System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations (Class II, 1 clearances)
• PHP — System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection (Class III)
• PJG — Cancer-Related Germline Gene Mutation Detection System (Class III)
• PKB — Autosomal Recessive Carrier Screening Gene Mutation Detection System (Class II, 1 clearances)
• PKW — Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase (Class III)
• PLS — Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 (Class III)
• PPM — General Purpose Reagent (Class I, 16 clearances)
• PQP — Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System (Class III)
• PRB — Cervical Intraepithelial Neoplasia (Cin) Test System (Class II, 2 clearances)
• PSU — Jak2 Gene Mutation Detection Test (Class II, 2 clearances)
• PSY — Whole Slide Imaging System (Class II, 19 clearances)
• PZJ — Lynch Syndrome Test System (Class II, 4 clearances)
• PZM — Next Generation Sequencing Based Tumor Profiling Test (Class II, 7 clearances)
• PZZ — Digital Pathology Display (Class II, 3 clearances)
• QAZ — Cancer Predisposition Risk Assessment System (Class II, 4 clearances)
• QDC — Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies (Class II, 2 clearances)
• QDI — Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies (Class II, 1 clearances)
• QFI — Synthetic Next-Generation Sequencing Quality Control And Filler Material (Not classified)
• QFK — Tumor Gene Profiling Test (Not classified)
• QKF — Immunocytochemistry Assay, P16/Ki-67 (Class III)
• QKQ — Digital Pathology Image Viewing And Management Software (Class II, 13 clearances)
• QNC — Whole Exome Sequencing Constituent Device (Class II, 1 clearances)
• QNH — Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay (Class III)
• QPN — Software Algorithm Device To Assist Users In Digital Pathology (Class II, 2 clearances)
• QQT — Immunohistochemistry Assay, Antibody, Ki-67 (Class III)
• QSA — Circulating Tumor Cell (Ctc) Enrichment Device (Class II, 1 clearances)
• QUL — Immunohistochemistry Assay, Antibody, Folr1 (Class III)
• QVU — High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System. (Class II, 1 clearances)
• QYV — Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm (Class II, 1 clearances)
• QZJ — Immunohistochemistry Assay, Antibody, Claudin 18 (Class III)
• SBB — System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection (Class III)
• SBL — Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 (Class III)
• SBY — High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids (Class II, 1 clearances)
• SER — Immunohistochemistry Assay, Antibody, Met (Class III)
• SFH — Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis (Class II, 1 clearances)
• SFL — Nucleic Acid Based Assay, Microsatellite Instability (Class III)
• SFS — Revumenib Eligibility Detection System (Class II, 1 clearances)
• SGD — Kit D816v Mutation Detection System (HDE)
• SHW — Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis (Class II, 1 clearances)