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Singclean CE Approved Rapid High Sensitivity Multi-Specification Urine Microalbuminuria Test Kits (Colloidal Gold) for Kidney Disease

Name: Singclean CE Approved Rapid High Sensitivity Multi-Specification Urine Microalbuminuria Test Kits (Colloidal Gold) for Kidney Disease
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2095619495

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

High Sensitivity Detection: Detects microalbuminuria levels with high sensitivity at 20mg/L for accurate diagnosis.

CE Approved Quality: Product holds CE certification, ensuring compliance with European safety standards.

Multiple Format Options: Available in Strip, Cassette, and Midstream formats to suit different testing needs.

Rapid Result Reading: Results can be read within 3-5 minutes, providing quick diagnostic information.

Manufacturer Direct Supply: Sold directly by a manufacturer with 24 R&D engineers and 420 employees.

ODM Service Available: Custom branding and packaging services are available for partners.

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: ≤2.99h 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 purposes, serving as a supplementary method for diagnosing chronic kidney injury.

Q:What is the shelf life of the product?

The shelf life is 24 months. Once opened, strips packaged in a cask are valid for 30 days.

Q:When should the result be read?

Read the result within 3-5 minutes. Do not read the result after 10 minutes as it may be inaccurate.

Q:What does a positive result indicate?

A positive result indicates one colored line in the control region and no line in the test region, meaning albumin levels are above the cut-off value.

Q:Can the test kit be reused?

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