933 results · 43ms · Sources: EU EUDAMED, US FDA

VITROS® Automation Solutions

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TDX THYROXINE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EMIT THYROXINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PARAMOUNT THYROXINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIOCIRCUITS IOS T4 TEST CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CEDIA TOTAL T4 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OREIA-Q-TY, ENZYME IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only

FDA 510(k)
FDA Class 1 ·Microbiology

PREMIER PLATINUM HPSA

FDA 510(k)
FDA Class 1 ·Microbiology

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192

FDA 510(k)
FDA Class 1 ·Microbiology

QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR

FDA 510(k)
FDA Class 1 ·Microbiology

PYLORI IGG ELISA TEST SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST

FDA 510(k)
FDA Class 1 ·Microbiology

PYLORI IGG

FDA 510(k)
FDA Class 1 ·Microbiology

Premier HpSA Flex (619096)

FDA 510(k)
FDA Class 1 ·Microbiology

MODIFICATION TO: PREMIER PLATINUM HPSA

FDA 510(k)
FDA Class 1 ·Microbiology

HELICOBACTER PYLORI IGG ELISA

FDA 510(k)
FDA Class 1 ·Microbiology

ELISA TEST, SEROLOGY

FDA 510(k)
FDA Class 1 ·Microbiology