Hematology Kits and Packages

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Hematology and Pathology Devices
  7. Hematology Kits and Packages

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Section
864.7010

Flow cytometric test system for hematopoietic neoplasms.

Section
864.7040

Adenosine triphosphate release assay.

Section
864.7060

Antithrombin III assay.

Section
864.7100

Red blood cell enzyme assay.

Section
864.7140

Activated whole blood clotting time tests.

Section
864.7250

Erythropoietin assay.

Section
864.7275

Euglobulin lysis time tests.

Section
864.7280

Factor V Leiden DNA mutation detection systems.

Section
864.7290

Factor deficiency test.

Section
864.7300

Fibrin monomer paracoagulation test.

Section
864.7320

Fibrinogen/fibrin degradation products assay.

Section
864.7340

Fibrinogen determination system.

Section
864.7360

Erythrocytic glucose-6-phosphate dehydrogenase assay.

Section
864.7375

Glutathione reductase assay.

Section
864.7400

Hemoglobin A<sub>2</sub> assay.

Section
864.7415

Abnormal hemoglobin assay.

Section
864.7425

Carboxyhemoglobin assay.

Section
864.7440

Electrophoretic hemoglobin analysis system.

Section
864.7455

Fetal hemoglobin assay.

Section
864.7470

Glycosylated hemoglobin assay.

Section
864.7490

Sulfhemoglobin assay.

Section
864.7500

Whole blood hemoglobin assays.

Section
864.7525

Heparin assay.

Section
864.7660

Leukocyte alkaline phosphatase test.

Section
864.7675

Leukocyte peroxidase test.

Section
864.7695

Platelet factor 4 radioimmunoassay.

Section
864.7720

Prothrombin consumption test.

Section
864.7735

Prothrombin-proconvertin test and thrombotest.

Section
864.7750

Prothrombin time test.

Section
864.7825

Sickle cell test.

Section
864.7875

Thrombin time test.

Section
864.7900

Thromboplastin generation test.

Section
864.7925

Partial thromboplastin time tests.