10,000 results
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64ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 2
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Alinity m STI Assay
FDA 510(k)
FDA Class 2
·Microbiology
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
FDA 510(k)
FDA Class 2
·Microbiology
UBI MAGIWEL CMV IGG QUANTITATIVE
FDA 510(k)
FDA Class 2
·Microbiology
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
FDA 510(k)
FDA Class 2
·Microbiology
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
FDA 510(k)
FDA Class 2
·Microbiology
Solana C. difficile Assay
FDA 510(k)
FDA Class 2
·Microbiology
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
FDA 510(k)
FDA Class 2
·Microbiology
IMMUNO. IDENTIFICATION OF H. CAPSULATUM
FDA 510(k)
FDA Class 2
·Microbiology
MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
MODIFIED RUBAGEN
FDA 510(k)
FDA Class 2
·Microbiology
SAS SHIGELLA BOYDII TYPE 5 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
BIO-RAD PLATELIA TOXO IGG TMB
FDA 510(k)
FDA Class 2
·Microbiology
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
FDA 510(k)
FDA Class 2
·Microbiology
CMV BIO-BEAD TITRATION KIT
FDA 510(k)
FDA Class 2
·Microbiology
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k)
FDA Class 2
·Microbiology
xTAG Gastrointestinal Pathogen Panel (GPP)
FDA 510(k)
FDA Class 2
·Microbiology
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology