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Singclean Ivd HCG Rapid Pregnancy Test Kit for Near Patient Testing
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: Comparison studies show >99% agreement with commercially available tests across 250 specimens.
Low Limit of Detection: Detects HCG at concentrations 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.
Versatile Usage Scenarios: Suitable for self-testing, professional laboratory use, and near-patient testing.
CE Certified Product: Manufactured by a company with CE certification for medical diagnostic products.
ODM Service Available: Manufacturer offers ODM services with 24 R&D engineers and established production facilities.
Comprehensive Material Kit: Includes test strip, cassette, instructions, dropper, and desiccant for immediate use.
Consistent Precision: Results for HCG standards at the same concentration are consistent with uniform chromaticity.
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 limit of detection for this test kit?
A:
The limit of detection is 10mlU/mL, meaning it can detect HCG at a concentration of 10mlU/mL or greater.
Q:Can this test be used for self-testing?
A:
Yes, the kit is suitable for self-testing, professional laboratory use, and near-patient testing.
Q:Does the test kit show cross-reactivity with other hormones?
A:
No, the addition of LH, FSH, and TSH to specimens showed no cross-reactivity.
Q:What is the accuracy rate of this pregnancy test?
A:
Comparison studies with 250 urine specimens showed >99% agreement with commercially available tests.
Q:What materials are included in the kit?
A:
The kit includes 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:
Supplier replies will be sent to your registered email
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