Pregnancy Test Kit
- Accuracy: >99% from the day of the expected period1
- Detection Principle: hCG Monoclonal Antibody Colloidal Gold
- Analytical Sensitivity: 25 mIU/mL hCG
- Result Time: 5 Minutes
Product Description
Built for programmes, not one-off purchases. A high-sensitivity early pregnancy detection kit using monoclonal antibody technology to detect hCG hormone in urine with over 99% accuracy at detecting typical pregnancy hormone levels from the day of the expected period.1 The test may detect hCG, in some cases, as early as 5 days before the expected period.2 Clear line-based results in 5 minutes. Individually foil-wrapped for hygiene, each kit contains 5 test sticks and urine collection cups. A high-turnover OTC rapid diagnostic product essential for every pharmacy chain. The Pregnancy Test Kit is supplied to distributors, chains and private-label brands that need consistent, repeatable stock rather than a single trial order.
The numbers your listing team asks for first. The accuracy is >99% from the day of the expected period.1 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. On the Pregnancy Test Kit, the analytical sensitivity (detection limit) is 25 mIU/mL hCG, and the same value is checked at incoming inspection — not only on the sample you approve. Each stick is individually foil-wrapped and lot-coded, so a complaint, a stability question or a recall can be traced back to the exact production batch.
Private label, end to end. Logo and colourway on the product and packaging; multi-language manuals and quick-start guides; retail box, colour sleeve or bulk-pack options; custom configurations and accessory kits — plus the technical documentation your team needs to register the product under your own brand in the EU, and in the US where a 510(k) clearance is in place. 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.
Technical Specifications
| Model | PT-KIT-001 |
|---|---|
| Detection Principle | hCG Monoclonal Antibody Colloidal Gold |
| Analytical Sensitivity (Detection Limit) | 25 mIU/mL hCG, traceable to the hCG reference standard used in the analytical study |
| Accuracy | >99% from the day of the expected period1 |
| Result Time | 5 Minutes |
| Early Detection | May detect hCG, in some cases, as early as 5 days before the expected period2 |
| Result Display | Dual Line (C/T Lines) |
| Certifications | CE marking; FDA establishment registration |
| Kit Contents | 5 Individually Wrapped Test Sticks + 5 Cups |
| Shelf Life | 24 months from the date of manufacture; store at 2–30 °C in the sealed foil pouch |
| Manufacturer Quality System | ISO 13485:2016 Certified Facility |
Important Information
1 Over 99% accurate at detecting typical pregnancy hormone levels from the day of the expected period. Hormone levels vary between individuals. Some pregnant women may not have detectable amounts of hCG in urine on the first day of the missed period, or may have miscalculated the first day of their period.
2 The test may detect hCG, in some cases, as early as 5 days before the expected period.
Important note regarding negative results: some pregnant women will not be able to detect hCG in their urine this early. If you test negative before your missed period but think you may still be pregnant, re-test a few days after your missed period.
All results should be confirmed by a healthcare provider, especially when making decisions about future medical care. This product is intended for self-testing; read the instructions for use before use.
Product Highlights
A pregnancy test kit engineered for pharmacy chains and private-label programmes.
From the day of the expected period, at typical pregnancy hormone levels — see note 1 under Important Information.
Two-line strip format; the control line confirms the test ran correctly.
Held constant between batches, so repeat orders do not drift.
Detection limit from the analytical study, stated against the hCG reference standard.
Typical Applications
Suitable for Retail, Pharmacy and Home Healthcare Channels
This pregnancy test kit is suitable for pharmacy chains, home healthcare providers, clinics, telehealth programmes, and medical device importers looking for a certified line for bulk sourcing, distribution, or OEM cooperation.
OEM / ODM Customization
Built for private label. From branding to localised retail packaging, every detail can carry your brand.
Custom logo on the pregnancy test kit and its retail packaging.
Colour box, insert card and EAN / UPC barcode prepared from your artwork.
User manual and retail box localised into your target language.
Size, colour and packaging configuration can be adjusted to your specification.
Packaging & Trade Terms
| MOQ | 5,000 pcs for neutral packaging · 20,000 pcs for custom OEM order |
|---|---|
| Lead Time | 25–30 days after deposit |
| Sample | Sample available, dispatched within 3–5 working days |
| Packing Detail | Confirmed per SKU with the quotation |
| Payment Terms | T/T 30% deposit, 70% before shipment · L/C at sight for FCL |
| Loading Port | Ningbo or Shanghai, China |
Common Questions
Which standards does it meet?
CE marking, manufactured under an ISO 13485:2016 quality system.
Can the specification be customised?
Yes. Material, dimensions, colour, packaging and accessory mix can be adjusted to your specification from the OEM minimum order quantity.
What is the MOQ and lead time?
5,000 pcs for neutral packaging and 20,000 pcs for custom OEM; production takes 25–30 days after deposit.
Which certificates and documents come with the unit?
CE marking. Test reports, Declaration of Conformity and technical-file support are issued per destination market; certificate numbers are provided with the quotation.
Need Samples or OEM Details?
Tell us your target volume and destination market — we will arrange an evaluation sample and set out the branding, packaging and configuration options available at your quantity.
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