What certifications does the product have?

The product is CE certified for in vitro diagnostic use.

Singclean Rapid Igg/Igm Antibody Test for Infectious Disease

Name: Singclean Rapid Igg/Igm Antibody Test for Infectious Disease
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2046243845

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$2.50-4.00

1,000 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Model No.

Cassette/Card/Device

Model NO.

Igg/Igm Test Kit

Speciems

Human Wholeblood, Serum or Plasma.

Packing

Box, Carton

Feature 1

Fast Results in 2-15 Minutes

Feature 2

One Step Disinfection Tablets and Lancets

Feature 3

High Sensitivity and Specificity

Transportation

by Sea, by Air and by Delivery

Transport Package

Carton

Specification

1 test/box, 20 tests/box

Trademark

Singclean

Origin

China Mainland

HS Code

3002190000

Production Capacity

10, 0000PC /Month

Key features

Rapid Detection Time: Fast results in 2-15 minutes for quick diagnosis and screening.

High Sensitivity & Specificity: Ensures accurate qualitative detection of IgG and IgM antibodies.

All-in-One Kit Design: Includes all necessary reagents, lancets, and buffers; no equipment needed.

ODM Customization Available: ODM service available for customized models and packaging.

CE Certified Quality: Product holds CE certification for professional in vitro diagnostic use.

Professional Manufacturer: Established in 2003 with 420 employees and 24 R&D engineers.

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: ≤3.10h 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.