1,256 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k)
FDA Class 1
·Microbiology
BD MAX GBS ASSAY, BD MAX INSTRUMENT
FDA 510(k)
FDA Class 1
·Microbiology
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
FDA 510(k)
FDA Class 1
·Microbiology
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
FDA 510(k)
FDA Class 1
·Microbiology
GenePOC GBS LB
FDA 510(k)
FDA Class 1
·Microbiology
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
FDA 510(k)
FDA Class 1
·Microbiology
ARIES GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
Solana GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
FDA 510(k)
FDA Class 1
·Microbiology
AMPLIVUE GBS ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
FDA 510(k)
FDA Class 1
·Microbiology
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
FDA 510(k)
FDA Class 1
·Microbiology
Portrait GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
Panther Fusion GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
FDA 510(k)
FDA Class 1
·Microbiology
NeuMoDx GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
IDI-STREP B ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
XPERT, GENEXPERT DX SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
FDA classification
FDA Class 1
·Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
SKIN BIOPSY DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery