Part 864 Subpart H—Hematology Kits and Packages

FDA submissions for Part 864 Subpart H—Hematology Kits and Packages in the Hematology (HE) review panel, including product codes and regulations.

Section range: §§ 864.7010–864.7925

CFR Part: 864

Product Codes

Product CodeDevice NameRegulationClassDevices
PWDFlow Cytometric Test System For Hematopoietic Neoplasms864.701022
JWRAtp Release (Luminescence)864.704010
KHFAdenine Nucleotide Quantitation864.704010
DDQAntigen, Antiserum, Control, Antithrombin Iii864.706024
JBQAntithrombin Iii Quantitation864.7060256
JPEAntithrombin Iii, Two Stage Clotting Time Assay864.706021
JBECell Enzymes (Erythrocytic And Leukocytic)864.710021
LKZRed-Cell Count By Photometry864.710022
JBPActivated Whole Blood Clotting Time864.7140224
GGTAssay, Erythropoietin864.7250220
JBOTest, Euglobulin Lysis864.727521
NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr864.728026
NPRTest, Factor Ii G20210a Mutations, Genomic Dna Pcr864.728025
OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr864.728022
PHJSystem, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations864.728021
GGPTest, Qualitative And Quantitative Factor Deficiency864.72902190
GJTPlasma, Coagulation Factor Deficient864.7290279
QTYVon Willebrand Factor Assay864.729321
QLUAnti-Factor Xa Activity Test System, Apixaban864.729523
SACAdamts13 Activity Test System864.729721
SESNon-Factor Replacement Product Test System864.729821
JBNFibrin Monomer Paracoagulation864.730022
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control864.7320257
GHHFibrin Split Products864.7320228
MIFProthrombin Fragment 1.2864.732026
DARFibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control864.734020
DATFibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control864.734022
DAXFibrinogen And Split Products, Fitc, Antigen, Antiserum, Control864.734020
DAZFibrinogen And Split Products, Antigen, Antiserum, Control864.734020
GFKFibrinogen Determination Standards And Controls864.734021
GFXFibrinogen Standard864.734023
GILPlasma, Fibrinogen Control864.734028
GISTest, Fibrinogen864.7340213
KQJSystem, Fibrinogen Determination864.7340228
JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening864.736025
JBGGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot864.736020
JBHGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod864.736020
JBIGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition864.736020
JBJGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction864.736020
JBKGlucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic864.736020
JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative864.736022
JBMGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis864.736020
JLMIsoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase864.736021
JMBVisual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase864.736021
JMCNadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase864.736020
KQEAssay, Erythrocytic Glucose-6-Phosphate Dehydrogenase864.736021
GIIGlutathione, Red-Cell864.737520
JMHFluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase864.737520
KQFAssay, Glutathione Reductase864.737520
JPDHemoglobin A2 Quantitation864.7400213
GIQHemoglobin S864.741523
GKAAbnormal Hemoglobin Quantitation864.7415223
JCMControl, Hemoglobin, Abnormal864.7415212
JPBHemoglobin M864.741520
MLLHemoglobin C (Abnormal Hemoglobin Variant)864.741521
GHSAssay, Carboxyhemoglobin864.742525
JBDSystem, Analysis, Electrophoretic Hemoglobin864.7440226
GHAHemoglobin, Alkali Resistant864.745520
GHQStain, Fetal Hemoglobin864.745522
JPCHemoglobin F Quantitation864.745521
KQIAssay, Fetal Hemoglobin864.745524
LIMTest, Screening, For D Positive Fetal Rbc'S864.745522
LCPAssay, Glycosylated Hemoglobin864.74702249
NGBTest, Glycosylated Hemoglobin, Over The Counter864.747020
NOZAssay, 1,5-Anhydroglucitol (15ag)864.747022
GJCAssay, Sulfhemoglobin864.749020
GGFAcid Hematin864.750020
GGZOxyhemoglobin864.750022
GIGHemoglobinometer864.750023
GJZCyanomethemoglobin Reagent And Standard Solution864.750022
GKKCyanomethemoglobin864.750027
GLYOximeter To Measure Hemoglobin864.750025
KHGWhole Blood Hemoglobin Determination864.7500239
LGLAssay, Bart'S, Hemoglobin864.750022
QGUHemoglobin For Donor Testing864.750020
GFTProtamine Sulphate864.752522
JBRTest, Heparin Neutralization864.752523
KFFAssay, Heparin864.7525246
GHDTest, Leukocyte Alkaline Phosphatase864.766014
JCJAlkaline Phosphatase864.766010
GIATest, Leukocyte Peroxidase864.767513
LGOTest, Leukocyte Typing864.767515
LJXTest, Urine Leukocyte864.767517
LCOPlatelet Factor 4 Radioimmunoassay864.7695213
GGQTest, Prothrombin Consumption864.772022
JPFProthrombin-Proconvertin And Thrombotest864.773520
GJSTest, Time, Prothrombin864.77502127
ODVVitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System864.775021
GHMTest, Sickle Cell864.7825218
JBBSolubility, Hemoglobin, Abnormal864.782522
GJATest, Thrombin Time864.7875220
GJBThrombin864.787521
GKQTest, Thromboplastin Generation864.790011
GFOActivated Partial Thromboplastin864.7925252
GGOReagent, Thromboplastin And Control864.792521
GGWTest, Time, Partial Thromboplastin864.7925232
GITReagent & Control, Partial Thromboplastin Time864.792524
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