10,000 results · 81ms · Sources: EU EUDAMED, US FDA

WELLCOGEN BACTERIAL ANTIGEN KIT

FDA 510(k)
FDA Class 2 ·Microbiology

ANTIGEN CONTROL CELLS

FDA 510(k)
FDA Class 2 ·Microbiology

TOXOPLASMOSIS TEST KIT

FDA 510(k)
FDA Class 2 ·Microbiology

HSVI - IGG ELISA-KIT

FDA 510(k)
FDA Class 2 ·Microbiology

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (Panther System)

FDA 510(k)
FDA Class 2 ·Microbiology

CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)
FDA Class 2 ·Microbiology

PHADEBAS RAST PENICLLOYL G/V TEST

FDA 510(k)
FDA Class 2 ·Immunology

LINEZOLID, 30UG, BBL SENSI-DISC

FDA 510(k)
FDA Class 2 ·Microbiology

ADAMS SCIENTIFIC SENSITIVITY DISCS

FDA 510(k)
FDA Class 2 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)
FDA Class 2 ·Microbiology

BIOTROL RUB-E.I.A. TEST G

FDA 510(k)
FDA Class 2 ·Microbiology

IS-VZU IGG TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

BACTEC MGIT 960 SIRE KITS

FDA 510(k)
FDA Class 2 ·Microbiology

BIOTIS MODIFIED THAYER MARTIN

FDA 510(k)
FDA Class 2 ·Microbiology

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.

FDA 510(k)
FDA Class 2 ·Microbiology

FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System

FDA 510(k)
FDA Class 2 ·Microbiology

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

FDA 510(k)
FDA Class 2 ·Microbiology

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID

FDA 510(k)
FDA Class 2 ·Microbiology