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CE Certificated Singclean OEM HCG Pregnancy Test Kit Manufacturer Strip Cassette Midstream
US$1.60-4.80
200 Pieces
Sample price:US$4.80/piece.Request sample
Product profile
Customization
AvailableType
IVD ReagentSensitivity
10mlu/MlModel NO.
OriginalSpecimens
UrineMaterials Provided
Test Strip/Test Cassette/Test Midstream InstructioMaterials Required But Not Provided
Disposable Specimen Container TimerTransport Package
BoxSpecification
1 test/box, 5 tests/box,25tests/box, 40 tests/box,Trademark
SingcleanOrigin
ChinaProduction Capacity
50000PCS/DayKey features
High Accuracy Rate: Results show >99% agreement with commercially available tests based on 250 urine specimens.
Low Detection Limit: Detects HCG at a concentration of 10mlU/mL or greater, standardized to WHO International Standard.
No Cross-Reactivity: Shows no interference from LH, FSH, or TSH, ensuring high analytical specificity.
CE Certified: Product holds CE certification for quality and safety compliance.
ODM Service Available: Customization services including OEM and ODM are offered by the manufacturer.
Multiple Usage Scenarios: Suitable for self-testing, professional laboratory use, and near-patient testing.
Flexible Payment Terms: Accepts LC, T/T, D/P, PayPal, Western Union, and small-amount payments.
Fast Lead Time: Off-season lead time is within 15 workdays; peak season is one month.
Company profile

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service AvailableExport Year: 2022-12-20 CertifiedNearest Port: Ningbo Port, Shanghai PortAverage Response Time: ≤4.33h CertifiedTerms of Payment: LC, T/T, D/P, etc.
AI-Powered supplier vetting
SummaryThe supplier is a China-based medical-products factory headquartered in Hangzhou, Zhejiang, with 420 employees and operations established in the early 2000s. It reports seven production lines, a 17,000 m² manufacturing plant, ISO 9001:2015 and ISO 14001:2015 certification, OEM/ODM services, and stated antigen rapid test-kit capacity of 10 million pieces annually. Its products and services cover in-vitro diagnostics, absorbable hemostatic products, hyaluronic-acid-related medical products, and other medical devices. The supplier reports export coverage across multiple global regions, more than 120 export destinations in a company description, and delivery within 15 working days off-peak or one month during peak periods. Evidence supports strengths in factory operations, quality systems, production scale, customization, and R&D. After-sales capability, financial credibility, and specific customer cases are not sufficiently documented in the provided slices.
Supplier typeThe supplier is identified as a manufacturing factory in Hangzhou, China, with a limited-company structure and medical-device products as its main offering. This supports classification as a direct medical-products manufacturer rather than only a trading intermediary.
CertificationsThe supplier reports ISO 9001:2015 and ISO 14001:2015 certifications, along with other unspecified certifications. These explicitly indicate documented quality-management and environmental-management systems, although the unspecified certifications cannot be assessed further.
R&D capabilityThe supplier reports dedicated R&D engineers, more than 20 years of absorbable-biomaterials expertise, a strong R&D team, and ongoing development of medical and tissue-engineering products. The slices explicitly support substantial innovation activity and industry experience.
Production capacityThe supplier reports a 17,000 m² plant, seven production lines, daily capacity of 500,000 pieces in a company description, annual antigen rapid test-kit output of 10 million pieces, and stated delivery times of within 15 working days off-peak and one month during peak season. These figures provide explicit evidence of meaningful production scale and fulfillment capability.
Customization capabilityThe supplier explicitly offers OEM and ODM services according to client needs. This is direct evidence that it can support customized product development or manufacturing arrangements.
Product Q&A
Q:What is the sensitivity of the test kit?
A:
The limit of detection is 10mlU/mL, meaning it can detect HCG at concentrations of 10mlU/mL or greater.
Q:Is this test suitable for self-testing?
A:
Yes, the kit is designed for self-testing, professional laboratory use, and near-patient testing.
Q:Does the test cross-react with other hormones?
A:
No, the test shows no cross-reactivity with LH (500mlU/mL), FSH (1,000mlU/mL), or TSH (1,000ulU/mL).
Q:What materials are included in the package?
A:
Included items are the test strip, test cassette, test midstream, instructions for use, a dropper (for cassette only), and a desiccant.
Q:Do you offer OEM or ODM services?
A:
Yes, we provide OEM and ODM services for our pregnancy test kits.
Send Inquiry
*To:
Hangzhou Singclean Medical Products Co., Ltd.
Hangzhou Singclean Medical Products Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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