VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PHADEBASE HUMYLASE CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIAISON CMV IgM Serum Control Set

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

HUMAN PLASMA CONTROL FOR CEA-ROCHE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

REFRACTROL-SP

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELECSYS DIGOXIN CALCHECK 5

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

REP CHOLESTEROL PROFILE CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SAS HCG SERUM CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS HYBRITECH PSA QC, MODEL 37209

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Elecsys Estradiol III Calcheck

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELECSYS HCG STAT CALCHECK 5

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FDI GLUCOSE CONTROL SOLUTION FOR AVIVA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

GLUCOSE METER-CHECK SOLUTION FOR TAIDOC

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR

FDA 510(k)

FDA Class 1 ·Clinical Chemistry