What is the lead time for delivery?

Peak season lead time is one month, while off-season lead time is within 15 workdays.

Does the product have certifications?

Yes, the product holds CE Mark certification and the company is ISO9001:2015 certified.

Singclean Wholesale Rapid Diagnostic Test Blood Igg/Igm Colloidal Gold Test Kit CE Mark

Name: Singclean Wholesale Rapid Diagnostic Test Blood Igg/Igm Colloidal Gold Test Kit CE Mark
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 937143225

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-5.00

2,000 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Method

Colloidal Gold Method

Applicant

Fever, Cough, Shortness of Breath

Format

Cassette

Storage

4-30c Degree

Transportation

by Air

Time

10 Minutes

Relative Sensitivity

96%

Relative Specificity

98.29%

Accuracy

97.84%

Transport Package

20PCS/Box, 600PCS/CTN

Specification

1 test/box; 20 test/box; 50 test/box

Trademark

Singclean

Origin

China

HS Code

3002150090

Production Capacity

100 0000PCS/Month

Key features

Rapid Detection: Provides qualitative and differential detection of IgG and IgM antibodies in 10-15 minutes.

High Accuracy: Features 96% relative sensitivity, 98.29% relative specificity, and 97.84% accuracy.

CE Certified: Product holds CE Mark certification for quality and safety compliance.

OEM/ODM Service: Full customization options available for manufacturers and trading companies.

Versatile Sample Types: Compatible with human whole blood, serum, or plasma for testing.

Complete Kit Package: Includes test cassettes, swabs, extraction tubes, droppers, and buffers.

Quality Assurance: 100% visual and function inspection for finished products by 66 QA inspectors.

Company profile

Importers and ExportersExhibition Experience

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

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: ≤3.54h

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.