Digital Pregnancy Test

Product Description

Digital clarity with a reusable monitor. The Digital Pregnancy Test combines a reusable electronic monitor with disposable hCG test sticks to deliver unambiguous digital results on an LCD screen. The display reads HCG1+ (conceived approximately 1–2 weeks ago), HCG2+ (2–3 weeks), HCG3+ (more than 3 weeks), HCG- (not pregnant), or HCG (test stick inserted / ready). Built on hCG monoclonal antibody colloidal gold technology, it achieves >99% accuracy from the day of the expected period and can detect hCG as early as 4 days before the missed period. Results appear in approximately 5 minutes and remain on-screen for about 60 minutes. After testing, simply eject the used stick and store the monitor for the next test.

The numbers your listing team asks for first. Accuracy is supported by a multi-center clinical evaluation comparing the digital test against a commercially available urine membrane hCG test: 100 specimens (60 negative, 40 positive) demonstrated 100% overall agreement, yielding >99% accuracy. Analytical sensitivity is 25 mIU/mL hCG, standardized to the W.H.O. Third International Standard. Specificity is confirmed against LH (500 mIU/mL), FSH (1,000 mIU/mL) and TSH (1,000 μIU/mL) with no cross-reactivity. Every figure comes from the technical file, so the same value appears on the quotation, on the label and in the registration dossier.

Specified for the way it is actually used. The digital display eliminates user interpretation error — a major advantage over line-based tests for pharmacy chains, telehealth programmes and first-time users. The gestational-age indication (HCG1+ / HCG2+ / HCG3+) provides clinical context that simple line tests cannot offer. Each test stick is individually foil-wrapped and lot-coded; the monitor stores used-stick history so traceability extends across multiple tests.

Private label, end to end. Logo and colourway on the monitor housing and packaging; multi-language manuals and quick-start guides; retail box, colour sleeve or bulk-pack options; flexible kit configurations (1 monitor + 1 stick, or 1 monitor + 5 sticks) — plus the technical documentation your team needs to register the product under your own brand in the EU (DIMDI registration support on file). Branding options, minimum quantities and lead times are detailed in OEM / ODM Customization below.

Certified production, not just certified samples. Every order runs in an ISO 13485:2016 certified facility and ships with CE marking, with FDA establishment registration records on file. Established applications include pharmacy retail programmes, private-label programmes and regional medical distribution. Send us your target volume and destination market — we quote MOQ, lead time and FOB price against those two numbers.