What certifications does the test kit have?

The kit is certified with CE, ISO 13485, and FSC.

What is the minimum order quantity?

The minimum order quantity is 10 pieces.

Human Use for Public CE; ISO 13485; FSC Certificates Antibody Igm/Igg Test Kit

Name: Human Use for Public CE; ISO 13485; FSC Certificates Antibody Igm/Igg Test Kit
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2112691994

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-2.50

500 Pieces

Sample price:US$5.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Certificates

CE; ISO 13485; FSC

Model NO.

IVD

Shipment

by Air or by Sea

Feature 1

Fast Results in 10-15 Minutes

Feature 2

Over 95% Sensitivity and Specificity

Feature 3

Have Stock, Ready to Ship

Transport Package

Carton or Customized Package

Specification

1 test/box; 20 test/box; 600pcs/carton

Trademark

Singclean

Origin

China

HS Code

3002190000

Production Capacity

1000000PCS/Month

Key features

Fast Results: Obtain test results in 10-15 minutes using colloidal gold method.

High Accuracy: Features over 95% sensitivity and specificity for reliable detection.

Multiple Certifications: Holds CE, ISO 13485, and FSC certificates for public use.

Ready to Ship: Products are in stock and ready for immediate shipment.

OEM/ODM Service: Full customization options available for manufacturing needs.

Versatile Sample Types: Detects IgG and IgM antibodies in whole blood, serum, or plasma.

Comprehensive Kit: Includes swabs, extraction tubes, buffers, and lancets for complete testing.

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: ≤3.58h

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.