What is the lead time for production?

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

Is OEM service available?

Yes, OEM and ODM services are available for this product.

CE; ISO 13485; FSC Certificates Infectious Virus Detection Device One Step Flu a/B Antigen Test Kit

Name: CE; ISO 13485; FSC Certificates Infectious Virus Detection Device One Step Flu a/B Antigen Test Kit
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2111844744

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.70-0.90

1,000 Pieces

Sample price:US$3.50/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent, Ivd Reagent

Material

Plastic

Model NO.

Flu A/B

Group

Adult

Ethylene Oxide Sterilization

Quality Guarantee Period

Logo Printing

Origin

China

Key features

Rapid 15-Min Results: Get qualitative detection results for IgG and IgM antibodies in just 15 minutes.

High Sensitivity & Specificity: Ensures accurate and reliable differential detection of antibodies in blood, serum, or plasma.

Multiple Certifications: Complies with CE, ISO 13485, and FSC standards for quality and safety.

Full OEM/ODM Customization: Supports full customization including logo printing and product specifications.

Comprehensive Kit Contents: Includes test cassettes, swabs, extraction tubes, buffer, and detailed instructions.

Flexible Packaging Options: Available in 20-test kits (600 pcs/carton) or 1-test kits (400-500 pcs/carton).

Professional Manufacturer: Established in 2003 with 546 employees, 10 production lines, and 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: ≤4.91h

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.