543 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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