PT-KIT-001 pregnancy test kit with test sticks and urine cups Result window and control lines of the PT-KIT-001 test stick PT-KIT-001 pregnancy test stick in use Retail box of the PT-KIT-001 pregnancy test kit for pharmacy distribution

Pregnancy Test Kit

Model PT-KIT-001 | 25 mIU/mL hCG | 5-minute result | CE marked | MOQ from 5,000 pcs (20,000 OEM)
  • 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
Request FOB Price & MOQ

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

Technical specifications of the Pregnancy Test Kit PT-KIT-001
ModelPT-KIT-001
Detection PrinciplehCG 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 Time5 Minutes
Early DetectionMay detect hCG, in some cases, as early as 5 days before the expected period2
Result DisplayDual Line (C/T Lines)
CertificationsCE marking; FDA establishment registration
Kit Contents5 Individually Wrapped Test Sticks + 5 Cups
Shelf Life24 months from the date of manufacture; store at 2–30 °C in the sealed foil pouch
Manufacturer Quality SystemISO 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.

Accuracy: >99%1

From the day of the expected period, at typical pregnancy hormone levels — see note 1 under Important Information.

Result Display: Dual Line (C/T Lines)

Two-line strip format; the control line confirms the test ran correctly.

Detection Principle: hCG Monoclonal Antibody Colloidal Gold

Held constant between batches, so repeat orders do not drift.

Analytical Sensitivity: 25 mIU/mL hCG

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.

Logo & Branding

Custom logo on the pregnancy test kit and its retail packaging.

Private-Label Packaging

Colour box, insert card and EAN / UPC barcode prepared from your artwork.

Market-Ready Manuals

User manual and retail box localised into your target language.

Flexible Configuration

Size, colour and packaging configuration can be adjusted to your specification.

Packaging & Trade Terms

MOQ5,000 pcs for neutral packaging · 20,000 pcs for custom OEM order
Lead Time25–30 days after deposit
SampleSample available, dispatched within 3–5 working days
Packing DetailConfirmed per SKU with the quotation
Payment TermsT/T 30% deposit, 70% before shipment · L/C at sight for FCL
Loading PortNingbo 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.

Request Samples & OEM Details

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