10,000 results · 47ms · Sources: EU EUDAMED, US FDA

Xpert MRSA/SA SSTI

FDA registration
CEPHEID·2 products·🇺🇸 United States

OrthoPro

FDA registration
ORTHOMED DEL SOL, S.A.·1 product·🇨🇷 Costa Rica

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas KRAS Mutation Test

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDx

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLICOR HCV TEST, V2.0/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0

ANA 2000 Capsules 2 Spill 450 count

FDA UDI
Wykle Research, Inc·00853383006806·

ANA 2000 Capsules 3 Spill 450 count

FDA UDI
Wykle Research, Inc·00853383006790·

ANA 70 Capsules 2 Spill 450 count

FDA UDI
Wykle Research, Inc·00853383006905·

ZEUS IFA ANA HEp-2 Test System

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533001809·The ZEUS IFA ANA HEp-2 Test System is a pre-sta...

IFA ANA Hep-2 Bulk Test System

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533001373·The ZEUS IFA ANA HEp-2 Test System is a pre-sta...

EliA ANA 3 Positive Control 2500/5000

FDA UDI
Phadia AB·07333066021331·EliA ANA 3 Positive Control 2500/5000

ANA 70 Capsules 1 Spill 450 count

FDA UDI
Wykle Research, Inc·00853383006899·

ANA 70 Capsules 3 Spill 50 count

FDA UDI
Wykle Research, Inc·00853383006882·

IFA ANA Rat Liver Tissue Test System

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533001359·The ZEUS IFA ANA Rat Liver Tissue Test System i...

ANA 2000 Capsules 1 Spill 50 count

FDA UDI
Wykle Research, Inc·00853383006981·

ANA 70 Capsules 1 Spill 50 count

FDA UDI
Wykle Research, Inc·00853383006868·

ANA 70 Capsules 2 Spill 50 count

FDA UDI
Wykle Research, Inc·00853383006875·

ANA 70 Capsules 3 Spill 450 count

FDA UDI
Wykle Research, Inc·00853383006912·