BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alinity i Total ß-hCG Reagent Kit, Alinity i System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica IM Total hCG (ThCG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access Total ßhCG (5th IS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BETA-HCG ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SERUM HCG MICROASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ONE-STEP HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABSOLUTE HCG PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS HCG AND BETA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIMSTICK PBD COMBO PREGNANCY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HYGEIA URINE PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry