Hematology

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Code	Device name	Class	21 CFR	510(k) (3y)
JPC	Hemoglobin F Quantitation	Class 2	21 CFR 864.7455	1
JPD	Hemoglobin A2 Quantitation	Class 2	21 CFR 864.7400	13
JPE	Antithrombin Iii, Two Stage Clotting Time Assay	Class 2	21 CFR 864.7060	1
JPF	Prothrombin-Proconvertin And Thrombotest	Class 2	21 CFR 864.7735
JPH	Test, Erythrocyte Sedimentation Rate	Class 1	21 CFR 864.6700	7
JPI	Device, Hematocrit Measuring	Class 2	21 CFR 864.6400	15
JPJ	Red-Cell Indices, Calculated	Class 2	21 CFR 864.5300	3
JPK	Mixture, Hematology Quality Control	Class 2	21 CFR 864.8625	192
JTS	Stains, Microbiologic	Class 1	21 CFR 864.1850	40
JWO	Device, Blood Volume Measuring	Class 2	21 CFR 864.5950	3
JWR	Atp Release (Luminescence)	Class 1	21 CFR 864.7040
KFC	Methylene Blue, Tissue Stain	Class 1	21 CFR 864.1850	7
KFD	Aniline Blue	Class 1	21 CFR 864.1850	1
KFE	Neutral Red	Class 1	21 CFR 864.1850	1
KFF	Assay, Heparin	Class 2	21 CFR 864.7525	46
KHE	Reagent, Occult Blood	Class 2	21 CFR 864.6550	97
KHF	Adenine Nucleotide Quantitation	Class 1	21 CFR 864.7040
KHG	Whole Blood Hemoglobin Determination	Class 2	21 CFR 864.7500	39
KIP	Formulations, Balanced Salt Solutions	Class 1	21 CFR 864.2875	17
KIQ	Kit, Culture, Chromosome	Class 1	21 CFR 864.2260	1
KIR	Cells, Animal And Human, Cultured	Class 1	21 CFR 864.2280	170
KIS	Sera, Animal And Human	Class 1	21 CFR 864.2800	45
KIT	Media And Components, Synthetic Cell And Tissue Culture	Class 1	21 CFR 864.2220	367
KIW	Kit, Mycoplasma Detection	Class 1	21 CFR 864.2360	2
KIX	Media, Mycoplasma Detection	Class 1	21 CFR 864.2360
KIY	Chamber, Slide Culture	Class 1	21 CFR 864.2240	1
KIZ	Dish, Tissue Culture	Class 1	21 CFR 864.2240	8
KJA	Flask, Tissue Culture	Class 1	21 CFR 864.2240	13
KJB	Apparatus, Roller	Class 1	21 CFR 864.2240	3
KJC	Bottle, Roller, Tissue Culture	Class 1	21 CFR 864.2240	3
KJD	Spinner, Flask	Class 1	21 CFR 864.2240
KJE	Spinner System, Cell Culture	Class 1	21 CFR 864.2240
KJF	System, Suspension, Cell Culture	Class 1	21 CFR 864.2240	4
KJH	Apparatus, Perfusion	Class 1	21 CFR 864.2240	3
KJK	Auramine O	Class 1	21 CFR 864.1850	2
KJL	Azure C	Class 1	21 CFR 864.1850
KJM	Bismarck Brown Y	Class 1	21 CFR 864.1850
KJN	Brilliant Cresyl Blue	Class 1	21 CFR 864.1850	1
KJO	Brilliant Green	Class 1	21 CFR 864.1850
KJP	Carmine	Class 1	21 CFR 864.1850
KJQ	Chlorazol Black E	Class 1	21 CFR 864.1850
KJR	Erythrosin B	Class 1	21 CFR 864.1850	3
KJS	Ethyl Eosin	Class 1	21 CFR 864.1850
KJT	Indigocarmine	Class 1	21 CFR 864.1850
KJW	Janus Green B	Class 1	21 CFR 864.1850
KJX	Jenner Stain	Class 1	21 CFR 864.1850	1
KJY	Malachite Green	Class 1	21 CFR 864.1850	1
KJZ	Martius Yellow	Class 1	21 CFR 864.1850
KKA	Methyl Orange	Class 1	21 CFR 864.1850
KKB	Methyl Violet 2b	Class 1	21 CFR 864.1850
KKC	Methylene Violet	Class 1	21 CFR 864.1850
KKD	Nigrosin	Class 1	21 CFR 864.1850
KKE	Orange Ii	Class 1	21 CFR 864.1850
KKF	Orcein	Class 1	21 CFR 864.1850
KKG	Protargol S	Class 1	21 CFR 864.1850
KKH	Tablet, Resazurin	Class 1	21 CFR 864.1850
KKI	Rose Bengal	Class 1	21 CFR 864.1850
KKJ	Sudan Iii	Class 1	21 CFR 864.1850	1
KKK	Sudan Iv	Class 1	21 CFR 864.1850	1
KKL	Thionin	Class 1	21 CFR 864.1850
KKM	Methylene Blue Thiocyanate	Class 1	21 CFR 864.1850
KKP	Solution, Silver Carbonate	Class 1	21 CFR 864.1850
KKQ	Sodium Periodate	Class 1	21 CFR 864.1850
KKR	Potassium Periodate	Class 1	21 CFR 864.1850
KKS	Acid, Periodic	Class 1	21 CFR 864.1850
KKT	Hematoxylin, Ehrlich'S	Class 1	21 CFR 864.1850
KKW	Basic Fuchsin	Class 1	21 CFR 864.1850
KPB	Media And Components, Mycoplasma Detection	Class 1	21 CFR 864.2360	4
KQC	Stains, Hematology	Class 1	21 CFR 864.1850	9
KQE	Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase	Class 2	21 CFR 864.7360	1
KQF	Assay, Glutathione Reductase	Class 2	21 CFR 864.7375
KQG	Instrument, Coagulation	Class 2	21 CFR 864.5400	14
KQH	Red-Cell Indices	Class 2	21 CFR 864.5300	1
KQI	Assay, Fetal Hemoglobin	Class 2	21 CFR 864.7455	4
KQJ	System, Fibrinogen Determination	Class 2	21 CFR 864.7340	28
KRX	Calibrator For Cell Indices	Class 2	21 CFR 864.8150	16
KRY	Calibrator For Platelet Counting	Class 2	21 CFR 864.8175	8
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Class 2	21 CFR 864.8165	25
KSA	Calibrator For Red-Cell And White-Cell Counting	Class 2	21 CFR 864.8185	8
KSB	Set, Transfer (Blood/Plasma)	Class 2	21 CFR 864.9875	6
KSD	Device, Heat-Sealing	Class 1	21 CFR 864.9750	1
KSE	Refrigerator, Freezer, Blood Storage	Class 2	21 CFR 864.9700	4
KSF	Kit, Quality Control For Blood Banking Reagents	Class 2	21 CFR 864.9650	12
KSG	Media, Potentiating For In Vitro Diagnostic Use	Class 2	21 CFR 864.9600	13
KSH	Chamber, Environmental For The Storage Of Platelet Concentrate	Class 2	21 CFR 864.9575
KSI	Lectins And Protectins	Class 2	21 CFR 864.9550	4
KSK	Solution, Stabilized Enzyme	Class 2	21 CFR 864.9400	5
KSL	Solution, Copper Sulfate For Specific Gravity Determinations	Class 1	21 CFR 864.9320	2
KSM	System, Test, Combs, Automated	Class 2	21 CFR 864.9300
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology	Class 2	21 CFR 864.9285	1
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Class 1	21 CFR 864.9275	1
KSP	Apparatus, Cell-Freezing And Reagents	Class 1	21 CFR 864.9225	1
KSQ	Device, Blood Mixing And Blood Weighing	Class 1	21 CFR 864.9195	8
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Compone	Class 2	21 CFR 864.9100	16
KSS	Supplies, Blood-Bank	Class 1	21 CFR 864.9050	6
KST	System, Blood Collection, Vacuum-Assisted, Manual	Class 1	21 CFR 864.9125
KSW	System, Processing For Frozen Blood	Class 2	21 CFR 864.9145	1
KSX	Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic	Class 2	21 CFR 864.9160	8
KSY	Boxes, View, Blood Grouping	Class 1	21 CFR 864.9185	1
KSZ	System, Test, Automated Blood Grouping And Antibody	Class 2	21 CFR 864.9175	4
KZL	Device, Warming. Blood And Plasma	Class 2	21 CFR 864.9205	4
LCO	Platelet Factor 4 Radioimmunoassay	Class 2	21 CFR 864.7695	13
LCP	Assay, Glycosylated Hemoglobin	Class 2	21 CFR 864.7470	249
LED	Stains, Chemical Solution	Class 1	21 CFR 864.1850	16
LEE	Stains, Dye Solution	Class 1	21 CFR 864.1850	1
LEF	Stains, Dye Powder	Class 1	21 CFR 864.1850	1
LGL	Assay, Bart'S, Hemoglobin	Class 2	21 CFR 864.7500	2
LGO	Test, Leukocyte Typing	Class 1	21 CFR 864.7675	5
LGP	Assay, Alpha-2-Antiplasmin	Class 2	21 CFR 864.5425	5
LGY	Trypan Blue	Class 1	21 CFR 864.1850	1
LIM	Test, Screening, For D Positive Fetal Rbc'S	Class 2	21 CFR 864.7455	2
LIZ	Assay, T Lymphocyte Surface Marker	Class 2	21 CFR 864.5220	7
LJD	Assay, B Lymphocyte Marker	Class 2	21 CFR 864.5220	1
LJX	Test, Urine Leukocyte	Class 1	21 CFR 864.7675	7
LKM	Counter, Urine Particle	Class 2	21 CFR 864.5200	15
LKZ	Red-Cell Count By Photometry	Class 2	21 CFR 864.7100	2
LLG	Kit, Igg, Platelet Associated	Class 2	21 CFR 864.5425	2
LNJ	Analyzer, Chromosome, Automated	Class 2	21 CFR 864.5260	11
LPI	Kit, Assay, Progesterone Receptor	Class 3	21 CFR 864.1860
LPJ	Kit, Assay, Estrogen Receptor	Class 3	21 CFR 864.1860
MAM	Dna-Probe, B And T Lymphocyte	Class 2	21 CFR 864.5220	1
MIF	Prothrombin Fragment 1.2	Class 2	21 CFR 864.7320	6
MLL	Hemoglobin C (Abnormal Hemoglobin Variant)	Class 2	21 CFR 864.7415	1
MMH	Blood Establishment Computer Software And Accessories	Class 2	21 CFR 864.9165
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor	Class 2	21 CFR 864.1860	13
MYA	Immunohistochemistry Antibody Assay, Estrogen Receptor	Class 2	21 CFR 864.1860	12
MYJ	Device, Mixing And Weighing, Semi-Automated	Class 2	21 CFR 864.9195
MYX	System, Blood Collection, Vacuum-Assisted, Automated	Class 1	21 CFR 864.9125
MZG	Test, Residual, Wbc In Leukoreduced Blood	Class 2	21 CFR 864.8625
NBK	System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer	Class 2	21 CFR 864.1860	1
NGB	Test, Glycosylated Hemoglobin, Over The Counter	Class 2	21 CFR 864.7470
NGK	Test, Occult Blood, Over The Counter	Class 2	21 CFR 864.6550
NID	Assay, Proliferation, In Vitro, T Lymphocyte	Class 2	21 CFR 864.5220	2
NJT	Immunohistochemistry Reagents And Kits	Class 1	21 CFR 864.1860
NJW	Control Material, Her-2/Neu, Immunohistochemistry	Class 2	21 CFR 864.1860	2
NKF	Immunohistochemistry Antibody Assay, C-Kit	Class 3	21 CFR 864.1860
NOT	Microscope, Automated, Image Analysis, Operator Intervention	Class 2	21 CFR 864.1860	13
NOZ	Assay, 1,5-Anhydroglucitol (15ag)	Class 2	21 CFR 864.7470	2
NPQ	Test, Factor V Leiden Mutations, Genomic Dna Pcr	Class 2	21 CFR 864.7280	6
NPR	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr	Class 2	21 CFR 864.7280	5
NQF	Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor	Class 3	21 CFR 864.1860
NQN	Microscope, Automated, Image Analysis, Immunohistochemistry,Operator I	Class 2	21 CFR 864.1860	15
NRF	Material, Quality Control, Semen Analysis	Class 2	21 CFR 864.8625	3
NRS	Control Material, Blood Circulating Epithelial Cancer Cell	Class 2	21 CFR 864.8625	1
NTR	Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P6	Class 1	21 CFR 864.1860	1
NVG	Tissue Culture, Accessories, Dental	Class 1	21 CFR 864.2240
OAO	Cord Blood Processing System And Storage Container	Class 2	21 CFR 864.9900
OBW	11-Dehydro Thromboxane B2 Kit, Urinary	Class 2	21 CFR 864.5700	1
ODV	Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping Sy	Class 2	21 CFR 864.7750	1
OEO	Automated Digital Image Manual Interpretation Microscope	Class 2	21 CFR 864.1860	6
OMM	Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna	Class 2	21 CFR 864.7280	2
OOF	Cryogenic Cord Blood Storage Container	Class 2	21 CFR 864.9900
OOX	Automated Occult Blood Analyzer	Class 2	21 CFR 864.6550	6
OQX	Self-Contained Blood Grouping	Class 2	21 CFR 864.9175
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class 2	21 CFR 864.9245
OSL	Control, Fecal Occult Blood	Class 2	21 CFR 864.6550	1
OYE	Flow Cytometric Reagents And Accessories.	Class 2	21 CFR 864.5220	8
PBC	Manual Blood Grouping And Antibody Test Systems	Class 2	21 CFR 864.9175
PDO	Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Charac	Class 2	21 CFR 864.1870	1
PDX	Flow Cytometry Calibrator	Class 2	21 CFR 864.5220
PFG	Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, He	Class 2	21 CFR 864.1870	1
PFK	Quality Control For Molecular Immunohematology Tests	Class 2	21 CFR 864.9650
PHJ	System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophi	Class 2	21 CFR 864.7280	1
PKG	Bone Marrow Processing Device To Support Hematopoietic Reconstitution	Class 2	21 CFR 864.9245
PMG	Automated Multicolor Fluorescent Imaging Cytometric Analysis System	Class 2	21 CFR 864.5220	1
PMQ	Peripheral Blood Processing Device For Wound Management	Class 2	21 CFR 864.9245
POV	Semen Analysis Device	Class 2	21 CFR 864.5220	28
PWD	Flow Cytometric Test System For Hematopoietic Neoplasms	Class 2	21 CFR 864.7010	2
QFR	Coagulation System For The Measurement Of Whole Blood Viscoelastic Pro	Class 2	21 CFR 864.5430	8
QGU	Hemoglobin For Donor Testing	Class 2	21 CFR 864.7500
QHR	Blood Grouping Reagent	Class U	21 CFR 660.20
QHS	Anti-Human Globulin	Class U	21 CFR 660.50
QHT	Reagent Red Blood Cells	Class U	21 CFR 660.30
QKF	Immunocytochemistry Assay, P16/Ki-67	Class 3	21 CFR 864.1860
QLU	Anti-Factor Xa Activity Test System, Apixaban	Class 2	21 CFR 864.7295	3
QNH	Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay	Class 3	21 CFR 864.1860
QTY	Von Willebrand Factor Assay	Class 2	21 CFR 864.7293	1
QUL	Immunohistochemistry Assay, Antibody, Folr1	Class 3	21 CFR 864.1860
QYC	Container System For The Processing And Storage Of Red Blood Cell Comp	Class 2	21 CFR 864.9115
QZJ	Immunohistochemistry Assay, Antibody, Claudin 18	Class 3	21 CFR 864.1860
SAC	Adamts13 Activity Test System	Class 2	21 CFR 864.7297	1
SAL	Device, Automated Cell Locating, Bone Marrow	Class 2	21 CFR 864.5261	1
SBL	Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4	Class 3	21 CFR 864.1860
SDP	Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna	Class 2	21 CFR 864.1861	1
SER	Immunohistochemistry Assay, Antibody, Met	Class 3	21 CFR 864.1860
SES	Non-Factor Replacement Product Test System	Class 2	21 CFR 864.7298	1
SFS	Revumenib Eligibility Detection System	Class 2	21 CFR 864.1885	1