1,504 results · 23ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA

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

FDA Pre-Market Approval
FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

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

FDA Pre-Market Approval
FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

ID NOW COVID-19 2.0

FDA 510(k)
FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)
FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)
FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)
FDA Class 2 ·Microbiology

Teal Wand

FDA 510(k)
FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

FDA classification
FDA Class 2 ·Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

Diode laser device (RF3120-BI)

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·cobas HCV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·cobas HCV Test