What is the minimum order quantity?

The minimum order quantity is 10 PCS.

Does the manufacturer offer customization?

Yes, full customization options including OEM and ODM services are available.

CE Approved Igm/Igg Antibody Rapid Diagnostic Test

Name: CE Approved Igm/Igg Antibody Rapid Diagnostic Test
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 931545475

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-4.10

1,000 Pieces

Sample price:US$50.00/set.Request sample

Product profile

Customization

Available

Use

Detection of Igg and Igm Antibodies

Speciems

Human Wholeblood, Serum or Plasma.

Certificates

CE; ISO 13485

Feature 1

Fast Results in 10-15 Minutes

Feature 2

One Step Disinfection Tablets and Lancets

Feature 3

High Sensitivity and Specificity

Relative Sensitivity

96%

Relative Specificity

98.29%

Accuracy

97.84%

Specification

1 test/box; 20 tests/box;

HS Code

3002150090

Production Capacity

300000/Day

Key features

Rapid 10-15 Min Results: Provides fast qualitative detection of IgG and IgM antibodies in just 10-15 minutes.

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

CE & ISO 13485 Certified: Fully certified with CE and ISO 13485 for professional in vitro diagnostic use.

All-in-One Kit Design: Includes test cassette, dropper, desiccant, buffer, alcohol pad, and lancet.

Full Customization Available: Offers full customization options for OEM and ODM services.

Easy On-Site Screening: Facilitates rapid diagnosis and screening with simple, time-saving operation.

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: ≤5.19h

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.