1,504 results
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23ms
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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
·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