543 results · 24ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 2 ·HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC

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

FDA Pre-Market Approval
FDA Class 2 ·HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC

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

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY

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

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

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

FDA Pre-Market Approval
FDA Class 2 ·ACCESS(R) HYBRITECH PSA ASSAY

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

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

COULTER 4C-EX 300 CELL CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

SYNCHRON SYSTEMS CREATININE REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

FDA 510(k)
FDA Class 2 ·Hematology

VISION (WITH OFF-LINE REVIEW)

FDA 510(k)
FDA Class 2 ·Radiology

IMMUNO-TROL LOW CELLS

FDA 510(k)
FDA Class 2 ·Hematology

GAMMAMEDPLUS IX SERIES HDR AFTERLOADER

FDA 510(k)
FDA Class 2 ·Radiology

SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COULTER BODY FLUID CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT

FDA 510(k)
FDA Class 2 ·Immunology

SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry