Pregaby Pregnancy Detection Test Kit

Product Overview:

Pregaby is a one-step rapid hCG immunochromatographic test cassette for early detection of pregnancy. Detects human chorionic gonadotropin (hCG) in urine at ≥25 mIU/mL. CE Marked, IVD. Results in 5–10 minutes.

Details

One-step qualitative immunochromatographic test for early pregnancy detection; detects hCG at ≥25 mIU/mL sensitivity in urine.

Primary Packaging

1 individually sealed pouch containing test cassette device and plastic dropper
Secondary Packaging

10 units per printed box (inner box) with product insert
Tertiary Packaging

Export shipper carton

Sealed pouch with test cassette, disposable plastic dropper, desiccant bag, urine tray, product information insert

Immunochromatography (two-site sandwich immunoassay) on nitrocellulose membrane using colloidal gold-labelled anti-hCG antibody

Store between 2–30°C; do not freeze; keep away from direct sunlight and excessive humidity

As per expiry date printed on the packaging

Single-use in-vitro diagnostic device; non-sterile

CE Marked; IVD; UK Device Registration No. UKDEVICEMFGIVD2021000079; For export only

Early detection capability; high sensitivity (≥25 mIU/mL); rapid results in 5–10 minutes; Specific, Sensitive & Precise; bilingual (Portuguese & French) labelling

For single use only; for in-vitro diagnostic use only; do not use after expiry date; store away from sunlight and moisture; consult a physician if result is positive

Reason of use

Early Pregnancy Detection

For early and rapid qualitative detection of human chorionic gonadotropin (hCG) in urine to confirm pregnancy.

Clinical Diagnosis Support

Assists healthcare professionals in confirming pregnancy prior to initiating medical or obstetric care.

Home & Point-of-Care Testing

Suitable for home use and point-of-care settings; delivers reliable results in 5–10 minutes.

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Pregaby Pregnancy Detection Test Kit