517 results · 45ms · Sources: EU EUDAMED, US FDA

ELECSYS PRECICONTROL TSH

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PRECISET AMMONIA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS HCG+B CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AUTOSTAT ANTI-DSDNA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS THYROGLOBULIN CALCHECK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SERACON-HDL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TRI-LEVEL LIGAND CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AXSYM LUTEINIZING HORMONE (LH)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DOCUMENT(R) ZERO

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SAS RSV CONTROL KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry