What payment methods are accepted?

We accept LC, T/T, D/P, PayPal, Western Union, and small-amount payments.

What is the lead time for production?

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

CE; ISO 13485; FSC Certificates One Step Flu a/B Antigen Test Kit

Name: CE; ISO 13485; FSC Certificates One Step Flu a/B Antigen Test Kit
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2111845674

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

Fast 15-Min Results: Obtain qualitative IgG/IgM antibody results in just 15 minutes using the Colloidal Gold Method.

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

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

Full Customization Support: Offers OEM/ODM services with full customization options for branding and packaging.

Easy to Use Design: Simple operation with all necessary components included for rapid testing procedures.

100% Quality Inspection: Every finished product undergoes visual and functional inspection by 66 QA/QC inspectors.

Flexible Payment Terms: Supports LC, T/T, D/P, PayPal, Western Union, and small-amount payments for convenience.

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: ≤5.01h

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.