Singclean Wholesale CE Approved Ivd Quick Profile One Step Lab Urine Microalbuminuria Test Device (Colloidal Gold) for Quick Results

Name: Singclean Wholesale CE Approved Ivd Quick Profile One Step Lab Urine Microalbuminuria Test Device (Colloidal Gold) for Quick Results
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2100666585

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-3.00

1,000 Pieces

Product profile

Customization

Available

Type

IVD Reagent

Transport Package

Carton or Customized Package

Specification

1pc/box; 25 pcs/box; 50 pcs/box; 100 pcs/box

Trademark

Singclean or Customized brand

Origin

China

HS Code

38220090

Production Capacity

10000/Day

Key features

CE Approved Certification: Product holds CE certification for in vitro diagnostic use.

High Sensitivity Detection: Detects albuminuria levels with a sensitivity of 20mg/L.

Rapid One-Step Results: Provides quick qualitative results within 3-5 minutes.

Multiple Format Options: Available in Strip, Cassette, and Midstream formats.

Small Sample Requirement: Requires only two drops of urine for cassette testing.

Manufacturer Direct Supply: Sold directly by manufacturer with 24 R&D engineers.

ODM Service Available: Customization services available for branded products.

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: ≤3.24h 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 intended use of this test kit?

It is intended for the qualitative determination of albuminuria levels in urine for in vitro diagnostic and as a supplementary method in diagnosing chronic kidney injury.

Q:What are the different testing formats available?

The product is available in three formats: Strip, Cassette, and Midstream, each with specific usage instructions.

Q:How do I interpret a positive result?

A positive result shows one colored line in the control region (C) and no line in the test region (T), indicating albumin levels exceed the cut-off value.

Q:Can the test kit be reused?

No, the test kit is for single use only and cannot be reused.

Q:What are the storage conditions after opening the package?

Once opened, the strips are valid for 30 days and must be kept tightly closed in a cool, dry place.