FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Diazyme DZ-Lite Total beta-hCG Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE

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

NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

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

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO E.P.T. PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPT CERTAINTY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PURE-AID PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTK PLUS. HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry