|
Section No. |
Regulation Name Product Code-Device Name |
Class |
|
864.1860 |
Immunohistochemistry reagents and kits. |
|
|
|
MXZ - Immunohistochemistry Assay, Antibody, Progesterone Receptor |
II |
|
|
MYA - Immunohistochemistry Antibody Assay, Estrogen Receptor |
II |
|
|
NJW - Control Material, Her-2/Neu, Immunohistochemistry |
II |
|
864.1870 |
Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization. |
|
|
|
PDO - Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization |
II |
|
|
PFG - Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders |
II |
|
864.5200 |
Automated cell counter. |
|
|
|
GKL - Counter, Cell, Automated (Particle Counter) |
II |
|
|
GKX - Instrument, Automated Platelet Counting |
II |
|
|
LKM - Counter, Urine Particle |
II |
|
864.5220 |
Automated differential cell counter. |
|
|
|
MAM - Dna-Probe, B And T Lymphocyte |
II |
|
|
OYE - Flow Cytometric Reagents And Accessories. |
II |
|
|
PMG - Automated Multicolor Fluorescent Imaging Cytometric Analysis System |
II |
|
|
POV - Semen Analysis Device |
II |
|
|
LIZ - Assay, T Lymphocyte Surface Marker |
II |
|
|
LJD - Assay, B Lymphocyte Marker |
II |
|
|
NID - Assay, Proliferation, In Vitro, T Lymphocyte |
II |
|
|
PDX - Flow Cytometry Calibrator |
II |
|
864.5260 |
Automated cell-locating device. |
|
|
|
JOY - Device, Automated Cell-Locating |
II |
|
864.5300 |
Red cell indices device. |
|
|
|
JBW - Red-Cell Indices, Measured |
II |
|
|
JPJ - Red-Cell Indices, Calculated |
II |
|
|
KQH - Red-Cell Indices |
II |
|
864.5400 |
Coagulation instrument. |
|
|
|
GKN - Timer, Clot, Automated |
II |
|
|
GKP - Instrument, Coagulation, Automated |
II |
|
|
KQG - Instrument, Coagulation |
II |
|
864.5425 |
Multipurpose system for in vitro coagulation studies. |
|
|
|
JPA - System, Multipurpose For In Vitro Coagulation Studies |
II |
|
|
LGP - Assay, Alpha-2-Antiplasmin |
II |
|
|
LLG - Kit, Igg, Platelet Associated |
II |
|
864.5680 |
Automated heparin analyzer. |
|
|
|
JOX - Analyzer, Heparin, Automated |
II |
|
864.5700 |
Automated platelet aggregation system. |
|
|
|
GHR - Reagent, Platelet Aggregation |
II |
|
|
JOZ - System, Automated Platelet Aggregation |
II |
|
|
OBW - 11-Dehydro Thromboxane B2 Kit, Urinary |
II |
|
864.5950 |
Blood volume measuring device. |
|
|
|
JWO - Device, Blood Volume Measuring |
II |
|
864.6550 |
Occult blood test. |
|
|
|
GGG - Guaiac Reagent |
II |
|
|
JIO - Blood, Occult, Colorimetric, In Urine |
II |
|
|
JIP - Blood, Occult, Enzymatic Method, In Urine |
II |
|
|
KHE - Reagent, Occult Blood |
II |
|
|
OOX - Automated Occult Blood Analyzer |
II |
|
|
NGK - Test, Occult Blood, Over The Counter |
II |
|
864.6675 |
Platelet aggregometer. |
|
|
|
GKW - Aggregometer, Platelet, Thrombokinetogram |
II |
|
|
JBX - Aggregrometer, Platelet |
II |
|
|
JBY - Aggregometer, Platelet, Photo-Optical Scanning |
II |
|
864.7010 |
Flow cytometric test system for hematopoietic neoplasms. |
|
|
|
PWD - Flow Cytometric Test System For Hematopoietic Neoplasms |
II |
|
864.7060 |
Antithrombin III assay. |
|
|
|
DDQ - Antigen, Antiserum, Control, Antithrombin Iii |
II |
|
|
JBQ - Antithrombin Iii Quantitation |
II |
|
|
JPE - Antithrombin Iii, Two Stage Clotting Time Assay |
II |
|
864.7100 |
Red blood cell enzyme assay. |
|
|
|
JBE - Cell Enzymes (Erythrocytic And Leukocytic) |
II |
|
|
LKZ - Red-Cell Count By Photometry |
II |
|
864.7140 |
Activated whole blood clotting time tests. |
|
|
|
JBP - Activated Whole Blood Clotting Time |
II |
|
864.7250 |
Erythropoietin assay. |
|
|
|
GGT - Assay, Erythropoietin |
II |
|
864.7280 |
Factor V Leiden DNA mutation detection systems. |
|
|
|
OMM - Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr |
II |
|
864.7290 |
Factor deficiency test. |
|
|
|
GGP - Test, Qualitative And Quantitative Factor Deficiency |
II |
|
|
GJT - Plasma, Coagulation Factor Deficient |
II |
|
864.7320 |
Fibrinogen/fibrin degradation products assay. |
|
|
|
DAP - Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
II |
|
|
GHH - Fibrin Split Products |
II |
|
|
MIF - Prothrombin Fragment 1.2 |
II |
|
864.7340 |
Fibrinogen determination system. |
|
|
|
DAR - Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control |
II |
|
|
DAT - Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control |
II |
|
|
DAX - Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control |
II |
|
|
DAZ - Fibrinogen And Split Products, Antigen, Antiserum, Control |
II |
|
|
GFK - Fibrinogen Determination Standards And Controls |
II |
|
|
GIS - Test, Fibrinogen |
II |
|
|
KQJ - System, Fibrinogen Determination |
II |
|
864.7360 |
Erythrocytic glucose-6-phosphate dehydrogenase assay. |
|
|
|
JBF - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening |
II |
|
|
JBG - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot |
II |
|
|
JBH - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod |
II |
|
|
JBI - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition |
II |
|
|
JBJ - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction |
II |
|
|
JBK - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic |
II |
|
|
JBL - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative |
II |
|
|
JBM - Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis |
II |
|
|
JLM - Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase |
II |
|
|
JMB - Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase |
II |
|
|
JMC - Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase |
II |
|
|
KQE - Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase |
II |
|
864.7400 |
Hemoglobin A2 assay. |
|
|
|
JPD - Hemoglobin A2 Quantitation |
II |
|
864.7415 |
Abnormal hemoglobin assay. |
|
|
|
GIQ - Hemoglobin S |
II |
|
|
GKA - Abnormal Hemoglobin Quantitation |
II |
|
|
JPB - Hemoglobin M |
II |
|
|
MLL - Hemoglobin C (Abnormal Hemoglobin Variant) |
II |
|
864.7425 |
Carboxyhemoglobin assay. |
|
|
|
GHS - Assay, Carboxyhemoglobin |
II |
|
864.7440 |
Electrophoretic hemoglobin analysis system. |
|
|
|
JBD - System, Analysis, Electrophoretic Hemoglobin |
II |
|
864.7455 |
Fetal hemoglobin assay. |
|
|
|
GHA - Hemoglobin, Alkali Resistant |
II |
|
|
JPC - Hemoglobin F Quantitation |
II |
|
|
KQI - Assay, Fetal Hemoglobin |
II |
|
864.7490 |
Sulfhemoglobin assay. |
|
|
|
GJC - Assay, Sulfhemoglobin |
II |
|
864.7500 |
Whole blood hemoglobin assays. |
|
|
|
GGZ - Oxyhemoglobin |
II |
|
|
GIG - Hemoglobinometer |
II |
|
|
GJZ - Cyanomethemoglobin Reagent And Standard Solution |
II |
|
|
GKK - Cyanomethemoglobin |
II |
|
|
GLY - Oximeter To Measure Hemoglobin |
II |
|
|
KHG - Whole Blood Hemoglobin Determination |
II |
|
|
LGL - Assay, Bart'S, Hemoglobin |
II |
|
864.7525 |
Heparin assay. |
|
|
|
GFT - Protamine Sulphate |
II |
|
|
JBR - Test, Heparin Neutralization |
II |
|
|
KFF - Assay, Heparin |
II |
|
864.7695 |
Platelet factor 4 radioimmunoassay. |
|
|
|
LCO - Platelet Factor 4 Radioimmunoassay |
II |
|
864.7750 |
Prothrombin time test. |
|
|
|
ODV - Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System |
II |
|
864.7825 |
Sickle cell test. |
|
|
|
GHM - Test, Sickle Cell |
II |
|
|
JBB - Solubility, Hemoglobin, Abnormal |
II |
|
864.7875 |
Thrombin time test. |
|
|
|
GJA - Test, Thrombin Time |
II |
|
|
GJB - Thrombin |
II |
|
864.7925 |
Partial thromboplastin time tests. |
|
|
|
GFO - Activated Partial Thromboplastin |
II |
|
|
GGO - Reagent, Thromboplastin And Control |
II |
|
|
GGW - Test, Time, Partial Thromboplastin |
II |
|
|
GIT - Reagent & Control, Partial Thromboplastin Time |
II |
|
864.8100 |
Bothrops atrox reagent. |
|
|
|
JCO - Bothrops Atrox Reagent |
II |
|
864.8950 |
Russell viper venom reagent. |
|
|
|
GIR - Reagent, Russel Viper Venom |
I |
|
864.9650 |
Quality control kit for blood banking reagents. |
|
|
|
PFK - Quality Control For Molecular Immunohematology Tests |
II |
|