Stratus CS Acute Care BHCG CalPak

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·3 products·🇺🇸 United States

VITROS Total bhCG II Calibrator

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·3 products·🇺🇸 United States

RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS HCG ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT ARCHEITECT TOTAL B-HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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