450 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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AIA-PACK CTNI 2ND-GEN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA KIT
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ST AIA-PACK PA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ABBOTT HAVAB -M EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA KIT
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ST AIA-PACK PA
STARLIGHT, MODEL PD9012
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ABBOTT IMX(R) HAVAB(R)-M
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Models 2200DR and 1600DR Digital Stationary Radiographic Systems
FDA 510(k)
FDA Class 2
·Radiology
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
FDA 510(k)
FDA Class 2
·Immunology
ST AIA-PACK PROG III Calibrator Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry