10,000 results
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54ms
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Sources: EU EUDAMED, US FDA
chemagic DNA Blood200 kit
Device
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·On the market·32 countries
chemagic DNA CS200 kit
Device
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·On the market·32 countries
Eonis DNA Extraction kit
Device
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·On the market·32 countries
DNA Vitamin Stoffwechsel Test
Device
EU IVDR
·
Eu Ivd Class A
·Cerascreen GmbH·On the market·3 countries
IDS ANA Control Set
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·32 countries
Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
FDA UDI
LUMINEX CORPORATION·00840487101612·The Verigene® Respiratory Pathogens Flex Nuclei...
Respiratory Pathogens Flex (RP Flex) Amplification Tray
FDA UDI
LUMINEX CORPORATION·00840487101711·The Verigene® Respiratory Pathogens Flex Nuclei...
Respiratory Pathogens Flex (RP Flex) Amplification Tray
FDA UDI
NANOSPHERE, INC.·00857573006324·The Verigene® Respiratory Pathogens Flex Nucl...
Respiratory Pathogens Flex (RP Flex) Extraction Tray
FDA UDI
LUMINEX CORPORATION·00840487101667·The Verigene® Respiratory Pathogens Flex Nuclei...
Respiratory Pathogens Flex (RP Flex) Extraction Tray
FDA UDI
NANOSPHERE, INC.·00857573006263·The Verigene® Respiratory Pathogens Flex Nucl...
Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
FDA UDI
NANOSPHERE, INC.·00857573006164·The Verigene® Respiratory Pathogens Flex Nucl...
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE2
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
FDA Pre-Market Approval
FDA Class 3
·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.
FDA 510(k)
FDA Class 2
·Microbiology
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
FDA 510(k)
FDA Class 1
·Microbiology
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST
FDA 510(k)
FDA Class 1
·Microbiology
SNAP MYCOBACTERIA AVIUM COMPLEX
FDA 510(k)
FDA Class 1
·Microbiology
ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.
FDA 510(k)
FDA Class 1
·Microbiology
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
FDA 510(k)
FDA Class 1
·Microbiology
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST
FDA 510(k)
FDA Class 1
·Microbiology