Women's Health

HCG Pregnancy Rapid Test

Detects Human chorionic gonadotropin. colloidal-gold. Specimen: Urine / Serum.

HCG Pregnancy Rapid Test rapid diagnostic test — Progene Bio
Target / AnalyteHuman chorionic gonadotropin
Disease / IndicationPregnancy
SeriesWomen's Health
Methodcolloidal-gold
SpecimenUrine / Serum
RegulatoryCE
OEM/ODMAvailable — private label & custom panel

Direct Answer

This rapid test detects Human chorionic gonadotropin in Urine / Serum to support Pregnancy. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.

Intended Use

Detection of human chorionic gonadotropin (hCG) for pregnancy.

Clinical Context

hCG is the standard pregnancy hormone; rapid tests detect early pregnancy from urine or serum.

Test Principle

Colloidal-gold immunochromatography (lateral flow). The device captures the target analyte (antigen or antibody) on a membrane via labeled antibodies, producing a visible test line within minutes. Qualitative or semi-quantitative, intended as a screening/triage aid — not a replacement for confirmatory laboratory testing.

Limitations

Very early or ectopic pregnancy may give low/negative results; confirm clinically.

Procurement

Specimen: urine / serum. Format: dipstick / midstream / cassette. CE-marked line (FDA status per product on request).

Interpretation

ResultLinesMeaning
PositiveTest + control lineTarget detected (presumptive positive)
NegativeControl line onlyBelow cut-off / not detected
InvalidNo control lineRepeat with a new device

Available SKUs (this series)

Cat. No.ProductSpecimenFormatKit SizeStatus
FHC-101 Pregnancy (hCG) Rapid Test Dipstick - 2.5 +9 variants Urine Dipstick 50 T, 100 T CE/FDA
FHC-201 Pregnancy (hCG) Rapid Test Dipstick +1 variants S/P/U Dipstick 50 T, 100 T CE
FHC-102 Pregnancy (hCG) Rapid Test Cassette +5 variants Urine Cassette 40 T CE/FDA
FHC-202 Pregnancy (hCG) Rapid Test Cassette +1 variants S/P/U Cassette 40 T CE
FHC-111 Pregnancy (hCG) Rapid Test Dipstick (Canister Pack) - 2.5 +5 variants Urine Dipstick 25 T CE
FHC-211 Pregnancy (hCG) Rapid Test Dipstick (Canister Pack) +1 variants S/P/U Dipstick 25 T CE
FHC-101H Pregnancy (hCG) Rapid Test Dipstick +2 variants Urine Dipstick 1 T CE0123/FDA
FHC-102H Pregnancy (hCG) Rapid Test Cassette +2 variants Urine Cassette 1 T CE0123/FDA
FHC-103 Pregnancy (hCG) Rapid Test Midstream +2 variants Urine Midstream No Box CE/FDA
FHC-103H Pregnancy (hCG) Rapid Test Midstream +2 variants Urine Midstream 1 T CE0123/FDA
FHC-103HI Pregnancy (hCG) Rapid Test Midstream With Indicator +1 variants Urine Midstream 1 T CE0123
FHC-402 Pregnancy (hCG) Rapid Test Cassette +1 variants WB/S/P Cassette 40 T CE

Documentation & quotation — datasheet, IFU, MOQ and OEM/ODM options on request.

Request IFU / Spec Sheet Request Datasheet

Last reviewed: 2026-09-12