2,252 results · 42ms · Sources: EU EUDAMED, US FDA

GAS TRAK PLUS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RANGE-CHEK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

THIRD GENERATION PSA CONTROL MODULE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BECKMAN VIGIL PLUS CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VIGIL PRX CHEMISTRY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIG/TDM A, B, C

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIAGNOSTIC REAGENT SET-RPLA

FDA 510(k)
FDA Class 1 ·Microbiology

CHEMISTRY CONTROL-LOW & HIGH TQC TM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AUTOCHECK6+

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry