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CE Certificated Singclean HCG Pregnancy Test Strip Cassette Midstream Rapid Test Kit
US$1.60-4.80
200 Pieces
Sample price:US$4.80/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Sensitivity

10mlu/Ml

Model NO.

Original

Specimens

Urine

Materials Provided

Test Strip/Test Cassette/Test Midstream Instructio

Materials Required But Not Provided

Disposable Specimen Container Timer

Transport Package

Box

Specification

1 test/box, 5 tests/box,25tests/box, 40 tests/box,

Trademark

Singclean

Origin

China

Production Capacity

50000PCS/Day

Key features

High Accuracy Rate: Over 99% agreement with commercially available tests in studies of 250 urine specimens.
Low Limit of Detection: Detects HCG at concentrations of 10 mIU/mL or greater using WHO International Standard.
No Cross-Reactivity: No interference from LH, FSH, or TSH ensures high analytical specificity.
CE Certified: Product holds CE certification for quality and safety compliance.
Versatile Usage: Suitable for self-testing, professional laboratory use, and near-patient testing.
ODM Service Available: Manufacturer offers ODM services for customized product solutions.
Rapid Result: One-step lateral flow immunoassay for quick qualitative detection of pregnancy.
Complete Kit Contents: Includes test strip, cassette, instructions, dropper, and desiccant.

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: ≤3.10h 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 10 mIU/mL, meaning it can detect HCG at this concentration or higher.
Q:Can this test be used 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 addition of LH, FSH, and TSH showed no cross-reactivity with negative and positive specimens.
Q:What is the accuracy of the test?
A:
Comparison studies showed over 99% agreement with commercially available tests on 250 urine specimens.
Q:What materials are included in the kit?
A:
The kit provides a test strip, test cassette, midstream instructions, dropper, and desiccant.

Send Inquiry

*To:Hangzhou Singclean Medical Products Co., Ltd.Hangzhou Singclean Medical Products Co., Ltd.
*Content:
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