10,000 results · 54ms · 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