589 results · 26ms · Sources: EU EUDAMED, US FDA

ST AIA-PACK AFP ENZYME IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Immunology

ST AIA-PACK INTACT PTH ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AIA-PACK TSH 3RD-GEN ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ST AIA-PACK CEA ENZYME IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Immunology

ST AIA-PACK hsE2 Calibrator Set

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AIA-PACK CTNI 2ND-GEN ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

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

FDA Pre-Market Approval
FDA Class 2 ·ST AIA-PACK PA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT HAVAB -M EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB-M (R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

STARLIGHT, MODEL PD9012

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery