PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Procalcitonin Assay

FDA classification

FDA Class 2 ·Procalcitonin Assay

Radioimmunoassay, Total Thyroxine

FDA classification

FDA Class 2 ·Radioimmunoassay, Total Thyroxine

Cryptosporidium Spp.

FDA classification

FDA Class 2 ·Cryptosporidium Spp.

Enzyme Linked Immunoabsorbent Assay, Rotavirus

FDA classification

FDA Class 1 ·Enzyme Linked Immunoabsorbent Assay, Rotavirus

Giardia Spp.

FDA classification

FDA Class 2 ·Giardia Spp.

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA classification

FDA Class 2 ·Kit, Test,Alpha-Fetoprotein For Testicular Cancer

Antigens, Cf (Including Cf Control), Adenovirus 1-33

FDA classification

FDA Class 1 ·Antigens, Cf (Including Cf Control), Adenovirus 1-33

System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

FDA classification

FDA Class 2 ·System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Antibodies, Gliadin

FDA classification

FDA Class 2 ·Antibodies, Gliadin

Autoantibodies, Endomysial(Tissue Transglutaminase)

FDA classification

FDA Class 2 ·Autoantibodies, Endomysial(Tissue Transglutaminase)

Hepatitis A Test (Antibody And Igm Antibody)

FDA classification

FDA Class 2 ·Hepatitis A Test (Antibody And Igm Antibody)

Radioimmunoassay, Acth

FDA classification

FDA Class 2 ·Radioimmunoassay, Acth

Reagents, Clostridium Difficile Toxin

FDA classification

FDA Class 1 ·Reagents, Clostridium Difficile Toxin

Fibrin Split Products

FDA classification

FDA Class 2 ·Fibrin Split Products

System, Test, Immunological, Antigen, Tumor

FDA classification

FDA Class 2 ·System, Test, Immunological, Antigen, Tumor

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

FDA classification

FDA Class 2 ·Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

System, Test, Carcinoembryonic Antigen

FDA classification

FDA Class 2 ·System, Test, Carcinoembryonic Antigen

Haptoglobin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Haptoglobin, Antigen, Antiserum, Control

Radioimmunoassay, Human Growth Hormone

FDA classification

FDA Class 1 ·Radioimmunoassay, Human Growth Hormone