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CE Singclean Urine Pregnancy Test Kit 10 Miu/Ml
US$1.60-4.80
200 Pieces
Sample price:US$4.80/piece.Request sample
Product profile
Customization
AvailableType
IVD ReagentSensitivity
10mlu/MlModel NO.
HCG 10 mIU/mlSpecimens
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
100000 PCS/YearKey features
High Accuracy: Over 99% agreement with commercial tests in studies of 250 urine specimens.
Low Detection Limit: Detects HCG at 10 mIU/mL or greater, standardized to WHO International Standard.
High Precision: Consistent results with uniform chromaticity for HCG standards at same concentration.
No Cross-Reactivity: No interference from LH, FSH, or TSH in negative and positive specimens.
Full Customization: OEM and ODM services available with full customization options.
Versatile Usage: Suitable for self-testing, professional laboratory use, and near-patient testing.
Quality Assurance: 100% finished product inspection including visual and function checks.
ISO Certified: Manufacturer certified with ISO9001:2015 management system.
Company profile
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Full Customization CertifiedExport Year: Shanghai Port CertifiedNearest Port: Shanghai PortAverage Response Time: ≤4.75h
AI-Powered supplier vetting
SummaryThe supplier is identified as a manufacturing factory in Hangzhou’s Qiantang District, with a business scope covering medical devices, cosmetics, masks, disinfectants, technical services, and import/export activities. It reports ISO 9001:2015 and CE certifications, 100% finished-product inspection, 58 quality assurance and control inspectors, and documented corrective-action and complaint-handling procedures. Manufacturing contracts with associated subcontractors are in place, and the supplier offers OEM, ODM, and broad customization services. However, it reports no in-stock capacity, overseas warehouse, overseas showroom, overseas agents or branches, or SDK availability. No new product was developed in the past year, and the company did not conduct regular fire drills during that period. Customer-case evidence is limited to OEM service for well-known brands and participation in one offline trade event.
Supplier typeThe supplier is explicitly identified as a factory, with associated companies in manufacturing. Its registered business scope includes first-category medical device production, second-category medical device sales, cosmetics, masks, disinfectants, technical services, and import/export activities.
CertificationsThe supplier reports an ISO 9001:2015 management-system certificate and CE certification for products. It also states that quality assurance exists and that quality-control processes are supported by documented procedures and records.
R&D capabilityThe supplier reports no available SDK and no new products during the past year, which are explicit limitations for software-enabled and recent product innovation. It does provide ODM services, but the available evidence does not establish strong ongoing innovation capability.
Production capacityThe supplier is a manufacturing factory with 100% finished-product inspection, 58 quality assurance and control inspectors, listed mixing, filling, sterilizing, and packing equipment, and a reported peak-season fulfillment time of one month. Valid manufacturing contracts with associated subcontractors are in place, although the supplier has no in-stock capacity.
Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, and full customization. It also provides ODM services and reports OEM capability for well-known brands, while its own-brand product quality-control capability covers Singclean and Singjoint.
Product Q&A
Q:What is the detection limit of this test kit?
A:
The limit of detection is 10 mIU/mL, standardized to the WHO International Standard.
Q:Is this test suitable for self-testing?
A:
Yes, it is suitable for self-testing, professional laboratory use, and near-patient testing.
Q:Does the test have cross-reactivity with other hormones?
A:
No, the addition of LH, FSH, and TSH showed no cross-reactivity in testing.
Q:What is the accuracy of this pregnancy test?
A:
The test shows over 99% agreement with commercially available tests in studies.
Q:Can I customize this product?
A:
Yes, OEM and ODM services are available with full customization options.
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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