Hematology

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Code	Device name	Class	21 CFR	510(k) (3y)
BSA	Warmer, Blood, Electromagnetic Radiation	Class 3	21 CFR 864.9205
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Class 2	21 CFR 864.9205	14
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Class 2	21 CFR 864.7320	58
DAR	Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control	Class 2	21 CFR 864.7340
DAT	Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control	Class 2	21 CFR 864.7340	2
DAX	Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control	Class 2	21 CFR 864.7340
DAZ	Fibrinogen And Split Products, Antigen, Antiserum, Control	Class 2	21 CFR 864.7340
DDQ	Antigen, Antiserum, Control, Antithrombin Iii	Class 2	21 CFR 864.7060	4
GFK	Fibrinogen Determination Standards And Controls	Class 2	21 CFR 864.7340	1
GFO	Activated Partial Thromboplastin	Class 2	21 CFR 864.7925	52
GFS	Standards And Controls, Hemoglobin, Normal And Abnormal	Class 2	21 CFR 864.8625	1
GFT	Protamine Sulphate	Class 2	21 CFR 864.7525	2
GFX	Fibrinogen Standard	Class 2	21 CFR 864.7340	3
GGC	Control, Plasma, Abnormal	Class 2	21 CFR 864.5425	40
GGF	Acid Hematin	Class 2	21 CFR 864.7500
GGG	Guaiac Reagent	Class 2	21 CFR 864.6550	1
GGH	Iron Stains	Class 1	21 CFR 864.1850	1
GGJ	Fluid, Diluting, White-Cell	Class 1	21 CFR 864.8200	1
GGK	Products, Red-Cell Lysing Products	Class 1	21 CFR 864.8540	29
GGL	Control, White-Cell	Class 2	21 CFR 864.8625	8
GGM	Control, Hemoglobin	Class 2	21 CFR 864.8625	15
GGN	Plasma, Coagulation Control	Class 2	21 CFR 864.5425	99
GGO	Reagent, Thromboplastin And Control	Class 2	21 CFR 864.7925	1
GGP	Test, Qualitative And Quantitative Factor Deficiency	Class 2	21 CFR 864.7290	190
GGQ	Test, Prothrombin Consumption	Class 2	21 CFR 864.7720	2
GGT	Assay, Erythropoietin	Class 2	21 CFR 864.7250	20
GGW	Test, Time, Partial Thromboplastin	Class 2	21 CFR 864.7925	32
GGX	Pipette, Sahli	Class 1	21 CFR 864.6160	2
GGY	Pipette, Diluting	Class 1	21 CFR 864.6160
GGZ	Oxyhemoglobin	Class 2	21 CFR 864.7500	2
GHA	Hemoglobin, Alkali Resistant	Class 2	21 CFR 864.7455
GHC	Tube, Sedimentation Rate	Class 1	21 CFR 864.6700	1
GHD	Test, Leukocyte Alkaline Phosphatase	Class 1	21 CFR 864.7660	4
GHH	Fibrin Split Products	Class 2	21 CFR 864.7320	28
GHK	Centrifuge, Microsedimentation	Class 1	21 CFR 864.5350
GHM	Test, Sickle Cell	Class 2	21 CFR 864.7825	18
GHO	Hemocytometer	Class 1	21 CFR 864.6160	2
GHQ	Stain, Fetal Hemoglobin	Class 2	21 CFR 864.7455	2
GHR	Reagent, Platelet Aggregation	Class 2	21 CFR 864.5700	11
GHS	Assay, Carboxyhemoglobin	Class 2	21 CFR 864.7425	5
GHY	Hematocrit, Tube, Rack, Sealer, Holder	Class 2	21 CFR 864.6400	2
GHZ	Solution, Gugol Blue	Class 1	21 CFR 864.1850
GIA	Test, Leukocyte Peroxidase	Class 1	21 CFR 864.7675	3
GIE	Fibrometer	Class 2	21 CFR 864.5400	2
GIF	Diluent, Blood Cell	Class 1	21 CFR 864.8200	38
GIG	Hemoglobinometer	Class 2	21 CFR 864.7500	3
GII	Glutathione, Red-Cell	Class 2	21 CFR 864.7375
GIL	Plasma, Fibrinogen Control	Class 2	21 CFR 864.7340	8
GIO	Tube, Collection, Capillary Blood	Class 1	21 CFR 864.6150	22
GIQ	Hemoglobin S	Class 2	21 CFR 864.7415	3
GIR	Reagent, Russel Viper Venom	Class 1	21 CFR 864.8950	16
GIS	Test, Fibrinogen	Class 2	21 CFR 864.7340	13
GIT	Reagent & Control, Partial Thromboplastin Time	Class 2	21 CFR 864.7925	4
GIZ	Plasma, Control, Normal	Class 2	21 CFR 864.5425	20
GJA	Test, Thrombin Time	Class 2	21 CFR 864.7875	20
GJB	Thrombin	Class 2	21 CFR 864.7875	1
GJC	Assay, Sulfhemoglobin	Class 2	21 CFR 864.7490
GJG	Pipette, Quantitative, Hematology	Class 1	21 CFR 864.6160	4
GJH	Stain, Reticulocyte	Class 1	21 CFR 864.1850	1
GJJ	Stains, Heinz Body	Class 1	21 CFR 864.1850
GJL	Romanowsky Stains	Class 1	21 CFR 864.1850	1
GJN	Fluid, Diluting, Red-Cell	Class 1	21 CFR 864.8200
GJP	Control, Platelet	Class 2	21 CFR 864.8625	4
GJR	Control, Red-Cell	Class 2	21 CFR 864.8625	5
GJS	Test, Time, Prothrombin	Class 2	21 CFR 864.7750	127
GJT	Plasma, Coagulation Factor Deficient	Class 2	21 CFR 864.7290	79
GJW	Pipette, Pasteur	Class 1	21 CFR 864.6160	4
GJZ	Cyanomethemoglobin Reagent And Standard Solution	Class 2	21 CFR 864.7500	2
GKA	Abnormal Hemoglobin Quantitation	Class 2	21 CFR 864.7415	23
GKB	Device, Automated Sedimentation Rate	Class 1	21 CFR 864.5800	2
GKE	Osmotic Fragility Testing	Class 1	21 CFR 864.6600
GKF	Instrument, Hematocrit, Automated	Class 2	21 CFR 864.5600	15
GKG	Centrifuge, Hematocrit	Class 2	21 CFR 864.6400	11
GKH	Apparatus, Automated Blood Cell Diluting	Class 1	21 CFR 864.5240	14
GKJ	Spinner, Slide, Automated	Class 1	21 CFR 864.5850	6
GKK	Cyanomethemoglobin	Class 2	21 CFR 864.7500	7
GKL	Counter, Cell, Automated (Particle Counter)	Class 2	21 CFR 864.5200	130
GKM	Hand-Tally, Differential	Class 1	21 CFR 864.6160	4
GKN	Timer, Clot, Automated	Class 2	21 CFR 864.5400	3
GKP	Instrument, Coagulation, Automated	Class 2	21 CFR 864.5400	49
GKQ	Test, Thromboplastin Generation	Class 1	21 CFR 864.7900	1
GKR	System, Hemoglobin, Automated	Class 2	21 CFR 864.5620	39
GKT	Separator, Automated, Blood Cell, Diagnostic	Class 2	21 CFR 864.9245	10
GKW	Aggregometer, Platelet, Thrombokinetogram	Class 2	21 CFR 864.6675
GKX	Instrument, Automated Platelet Counting	Class 2	21 CFR 864.5200	2
GKZ	Counter, Differential Cell	Class 2	21 CFR 864.5220	380
GLG	Platelet Counting, Manual	Class 1	21 CFR 864.6160	3
GLK	Control, Hematocrit	Class 2	21 CFR 864.8625	7
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Class 2	21 CFR 864.8625	10
GLY	Oximeter To Measure Hemoglobin	Class 2	21 CFR 864.7500	5
HYB	Eosin Y	Class 1	21 CFR 864.1850	10
HYC	Fast Green	Class 1	21 CFR 864.1850	1
HYD	Fast Red Salt B	Class 1	21 CFR 864.1850	1
HYE	Solution, Fontanna Silver	Class 1	21 CFR 864.1850
HYF	Giemsa Stain	Class 1	21 CFR 864.1850	4
HYG	Glenner'S Stain	Class 1	21 CFR 864.1850	1
HYH	Gold Chloride	Class 1	21 CFR 864.1850
HYI	Iodine, Grams	Class 1	21 CFR 864.1850	6
HYJ	Hematoxylin	Class 1	21 CFR 864.1850	14
HYK	Hematoxylin Harris'S	Class 1	21 CFR 864.1850	7
HYL	Hematoxylin Mayer'S	Class 1	21 CFR 864.1850
HYO	Hematoxylin Weigert'S	Class 1	21 CFR 864.1850	1
HYQ	Iron Chloride-Weigert	Class 1	21 CFR 864.1850
HYR	Leuco-Patent Blue	Class 1	21 CFR 864.1850
HYS	Light Green	Class 1	21 CFR 864.1850	1
HYT	Luxol Fast Blue	Class 1	21 CFR 864.1850
HYW	Stain, Trichrome, Mallory'S	Class 1	21 CFR 864.1850	2
HYY	Metanil Yellow	Class 1	21 CFR 864.1850
HYZ	Methenamine Silver	Class 1	21 CFR 864.1850
HZA	Methyl Green	Class 1	21 CFR 864.1850	2
HZC	Mucicarmine	Class 1	21 CFR 864.1850	2
HZD	Muller'S Colloidal Iron	Class 1	21 CFR 864.1850
HZE	Nile Blue	Class 1	21 CFR 864.1850
HZF	Nuclear Fast Red	Class 1	21 CFR 864.1850
HZG	Oil Red O	Class 1	21 CFR 864.1850	1
HZH	Orange G	Class 1	21 CFR 864.1850	4
HZJ	Stain, Papanicolau	Class 1	21 CFR 864.1850	15
HZL	Phloxine B	Class 1	21 CFR 864.1850	1
HZM	Hematoxylin, Acid, Phosphotungstic	Class 1	21 CFR 864.1850
HZN	Picro Methyl Blue	Class 1	21 CFR 864.1850
HZO	Stain, Ponceau	Class 1	21 CFR 864.1850	1
HZP	Pyronin	Class 1	21 CFR 864.1850
HZQ	Red-Violet Lb	Class 1	21 CFR 864.1850
HZR	Resorcin Fuchsin	Class 1	21 CFR 864.1850
HZS	Safranin	Class 1	21 CFR 864.1850	1
HZT	Reagent, Schiff	Class 1	21 CFR 864.1850	5
HZX	Silver Nitrate	Class 1	21 CFR 864.1850
HZY	Sirius Red	Class 1	21 CFR 864.1850
HZZ	Sudan Black B	Class 1	21 CFR 864.1850	2
IAA	Titan Yellow	Class 1	21 CFR 864.1850
IAB	Toluidine Blue	Class 1	21 CFR 864.1850	1
IAC	Van Gieson'S Stain	Class 1	21 CFR 864.1850	1
IAD	Van Gieson'S Picro-Fuchsin	Class 1	21 CFR 864.1850
IAE	Hematoxylin, Iron, Weigert'S	Class 1	21 CFR 864.1850	1
IAF	Wright'S Stain	Class 1	21 CFR 864.1850	33
ICC	Eosin B	Class 1	21 CFR 864.1850	1
ICD	Darrow Red	Class 1	21 CFR 864.1850
ICF	Crystal Violet For Histology	Class 1	21 CFR 864.1850	5
ICG	Cresyl Violet Acetate	Class 1	21 CFR 864.1850
ICH	Congo Red	Class 1	21 CFR 864.1850	1
ICI	Hematoxylin, Chrome Alum	Class 1	21 CFR 864.1850
ICJ	Carbol Night Blue	Class 1	21 CFR 864.1850	1
ICL	Carbol Fuchsin	Class 1	21 CFR 864.1850	4
ICM	Brilliant Yellow	Class 1	21 CFR 864.1850
ICN	Biebrich Scarlet	Class 1	21 CFR 864.1850	2
ICO	Best'S Carmine	Class 1	21 CFR 864.1850
ICQ	Azure A	Class 1	21 CFR 864.1850
ICR	Azocarmine B	Class 1	21 CFR 864.1850
ICS	Azocarmine G	Class 1	21 CFR 864.1850
ICT	Azan Counterstain	Class 1	21 CFR 864.1850
ICX	Aniline	Class 1	21 CFR 864.1850	1
ICY	Acid, Aniline, Fuchsin	Class 1	21 CFR 864.1850
ICZ	Ammoniacal Silver Hydroxide Silver Nitrate	Class 1	21 CFR 864.1850
IDA	Alcian Blue	Class 1	21 CFR 864.1850	2
IDB	Aldehyde Fuchsin	Class 1	21 CFR 864.1850
IDC	Acridine Orange	Class 1	21 CFR 864.1850	4
IDD	Alizarin Red	Class 1	21 CFR 864.1850
IDE	Acid, Hematein	Class 1	21 CFR 864.1850
IDF	Acid, Fuchsin	Class 1	21 CFR 864.1850	1
JBB	Solubility, Hemoglobin, Abnormal	Class 2	21 CFR 864.7825	2
JBD	System, Analysis, Electrophoretic Hemoglobin	Class 2	21 CFR 864.7440	26
JBE	Cell Enzymes (Erythrocytic And Leukocytic)	Class 2	21 CFR 864.7100	1
JBF	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening	Class 2	21 CFR 864.7360	5
JBG	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot	Class 2	21 CFR 864.7360
JBH	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod	Class 2	21 CFR 864.7360
JBI	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition	Class 2	21 CFR 864.7360
JBJ	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduct	Class 2	21 CFR 864.7360
JBK	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic	Class 2	21 CFR 864.7360
JBL	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative	Class 2	21 CFR 864.7360	2
JBM	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis	Class 2	21 CFR 864.7360
JBN	Fibrin Monomer Paracoagulation	Class 2	21 CFR 864.7300	2
JBO	Test, Euglobulin Lysis	Class 2	21 CFR 864.7275	1
JBP	Activated Whole Blood Clotting Time	Class 2	21 CFR 864.7140	24
JBQ	Antithrombin Iii Quantitation	Class 2	21 CFR 864.7060	56
JBR	Test, Heparin Neutralization	Class 2	21 CFR 864.7525	3
JBT	Timer, Coagulation	Class 2	21 CFR 864.5400
JBW	Red-Cell Indices, Measured	Class 2	21 CFR 864.5300
JBX	Aggregrometer, Platelet	Class 2	21 CFR 864.6675	12
JBY	Aggregometer, Platelet, Photo-Optical Scanning	Class 2	21 CFR 864.6675	2
JBZ	Study, Platelet Adhesive	Class 2	21 CFR 864.6650	3
JCA	Device, Bleeding Time	Class 2	21 CFR 864.6100	7
JCF	Lymphocyte Separation Medium	Class 1	21 CFR 864.8500	12
JCG	Fluid, Diluting, Manual Cell	Class 1	21 CFR 864.8200	1
JCH	Esterase	Class 1	21 CFR 864.1850
JCI	Acid Phosphatase, Cytochemical	Class 1	21 CFR 864.1850
JCJ	Alkaline Phosphatase	Class 1	21 CFR 864.7660
JCM	Control, Hemoglobin, Abnormal	Class 2	21 CFR 864.7415	12
JCN	Control, Cell Counter, Normal And Abnormal	Class 2	21 CFR 864.8625	12
JCO	Bothrops Atrox Reagent	Class 2	21 CFR 864.8100	7
JIO	Blood, Occult, Colorimetric, In Urine	Class 2	21 CFR 864.6550	11
JIP	Blood, Occult, Enzymatic Method, In Urine	Class 2	21 CFR 864.6550
JLM	Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase	Class 2	21 CFR 864.7360	1
JMB	Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase	Class 2	21 CFR 864.7360	1
JMC	Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase	Class 2	21 CFR 864.7360
JMH	Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase	Class 2	21 CFR 864.7375
JOX	Analyzer, Heparin, Automated	Class 2	21 CFR 864.5680	15
JOY	Device, Automated Cell-Locating	Class 2	21 CFR 864.5260	35
JOZ	System, Automated Platelet Aggregation	Class 2	21 CFR 864.5700	38
JPA	System, Multipurpose For In Vitro Coagulation Studies	Class 2	21 CFR 864.5425	181
JPB	Hemoglobin M	Class 2	21 CFR 864.7415