What is the shelf life of the kit?

The unopened kit has a shelf life of 24 months. Do not use beyond the expiration date printed on the sealed pouch.

Singclean High Accuracy CE Urine Pregnancy Test for Home

Name: Singclean High Accuracy CE Urine Pregnancy Test for Home
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2051650775

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-3.00

1,000 Pieces

Sample price:US$5.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Material

Plastic

Quality Guarante

2 Years

Sensitivity

92.15%-99.05%

Specificity

97.47%-99.61%

Accuracy

97.19%-99.33%

Lead Time

3-8 Days After Payment

Certification

CE, Doc, ISO, Who(in Application)

When to Test

Early Stage of Infection

Symptoms

Fever, Cough, Fatigue, Shortness of Breath

Test Time

10-15 Minutes

Sample

Nasal Swab

Storage

4-30 Degree

Main Market

Europe

Transport Package

Carton or Customized Package

Specification

20 tests/box, 1 test/box

Trademark

Singclean or Customized brand

Origin

China

HS Code

3002150050

Production Capacity

1 Million PCS/Week

Key features

High Diagnostic Accuracy: Clinical sensitivity 92.15%-99.05%, specificity 97.47%-99.61%, and accuracy 97.19%-99.33% validated against PCR.

Rapid 15-Minute Results: Get qualitative detection results for C-19 antigen in human saliva within 10-15 minutes.

CE Certified & Approved: Meets CE standards for in vitro diagnostic use, ensuring quality and safety for home testing.

No Equipment Required: Portable colloidal gold assay that is affordable and easy to administer without special instruments.

2-Year Quality Guarantee: Backed by a 2-year quality guarantee for reliability and customer confidence.

ODM Customization Available: ODM service available for customized branding and packaging solutions.

Trusted Manufacturer: Established in 2003 with 420 employees and 24 R&D engineers, ensuring professional production.

Company profile

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service AvailableExport Year: 2022-12-20 CertifiedNearest Port: Ningbo Port, Shanghai PortAverage Response Time: ≤2.83h 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:How long does it take to get results?

Results are ready in 10-15 minutes. The test provides a rapid, qualitative detection of the C-19 antigen.

Q:Is this test accurate compared to PCR?

Yes, clinical studies show sensitivity of 92.15%-99.05%, specificity of 97.47%-99.61%, and accuracy of 97.19%-99.33% when compared to RT-PCR assays.

Q:What does a positive result mean?

A positive result (C and T bands present) indicates the presence of C-19 antigen. You should contact a physician immediately for confirmation and follow local isolation guidelines.

Q:Can I reuse the test kit?

No, the test is for single use only. Do not re-use under any circumstances to ensure accuracy and safety.

Q:Is this test suitable for self-testing?

Yes, it is designed for non-professional self-testing. However, any reactive specimen must be confirmed with alternative testing methods and clinical findings.