10,000 results · 202ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)
FDA Class 2 ·Immunology

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT FREE PSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT TOTAL PSA

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

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

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·Elecsys total PSA and total PSA CalSet II

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

Progensa

FDA UDI
Hologic, Inc.·25420045500775·

Progensa

FDA UDI
Hologic, Inc.·15420045500747·

Progensa

FDA UDI
Hologic, Inc.·15420045500730·

Progensa

FDA UDI
Hologic, Inc.·15420045500822·

Method Verification Kit - PSA

FDA UDI
QUALIGEN INC.·00816467020075·

Prostate Specific Antigen (PSA)

FDA UDI
BIOCARE MEDICAL LLC·00847627024572·

Prostate Specific Antigen (PSA)

FDA UDI
BIOCARE MEDICAL LLC·00847627002426·

total PSA CalSet II

FDA UDI
Roche Diagnostics GmbH·07613336167496·

Elecsys Total PSA Immunoassay

FDA UDI
Roche Diagnostics GmbH·04015630921515·

Prostate Specific Antigen (PSA)

FDA UDI
BIOCARE MEDICAL LLC·00847627002419·

Elecsys Total PSA Immunoassay

FDA UDI
Roche Diagnostics GmbH·04015630920877·

Prostate Specific Antigen (PSA)

FDA UDI
BIOCARE MEDICAL LLC·00847627002440·

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE FPSA ASSAY