5,905 results
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49ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REAL TIME HBV CALIBRATOR KIT
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·OraQuick HCV Rapid Antibody Test
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SAS HCG-CHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO E.P.T. PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EPT CERTAINTY PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PURE-AID PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PTK PLUS. HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EARLY PREGNANCY DETECTION TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHOICE ACCU-TEST PREGNANCY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVATEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COUNTER CHECK, H001, H002, H003
FDA 510(k)
FDA Class 2
·Hematology
ST AIA-PACK AFP ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
FDA 510(k)
FDA Class 2
·Clinical Chemistry