VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

R&D GLU-LINE HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Test, Cystatin C

FDA classification

FDA Class 2 ·Test, Cystatin C

Radioimmunoassay, Acth

FDA classification

FDA Class 2 ·Radioimmunoassay, Acth

Radioimmunoassay, 17-Hydroxyprogesterone

FDA classification

FDA Class 1 ·Radioimmunoassay, 17-Hydroxyprogesterone

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, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA classification

FDA Class 3 ·Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

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

Hemoglobin A1c Test System

FDA classification

FDA Class 2 ·Hemoglobin A1c Test System

Ige, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Antigen, Antiserum, Control

Radioimmunoassay, Human Growth Hormone

FDA classification

FDA Class 1 ·Radioimmunoassay, Human Growth Hormone

Urinary Homocystine (Nonquantitative) Test System

FDA classification

FDA Class 2 ·Urinary Homocystine (Nonquantitative) Test System

Fluorometric Method, Cpk Or Isoenzymes

FDA classification

FDA Class 2 ·Fluorometric Method, Cpk Or Isoenzymes

Radioassay, Triiodothyronine Uptake

FDA classification

FDA Class 2 ·Radioassay, Triiodothyronine Uptake

Radioassay, Vitamin B12

FDA classification

FDA Class 2 ·Radioassay, Vitamin B12

Test, Natriuretic Peptide

FDA classification

FDA Class 2 ·Test, Natriuretic Peptide

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers