What certifications does the product have?

The product is CE approved and holds ISO certification. WHO approval is in application.

What is the lead time for delivery?

Lead time is 3-8 days after payment. During off-season, it is within 15 workdays; during peak season, it is one month.

CE Approved Singclean Antigen Test Kit with Whitelist

Name: CE Approved Singclean Antigen Test Kit with Whitelist
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 1929199775

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.30-2.00

500 Pieces

Product profile

Customization

Available

Type

IVD Reagent

Material

Plastic

Model NO.

Cassette

Quality Guarante

24 Months

Sensitivity

95.87%-99.51%

Specificity

97.18%-99.67%

Accuracy

97.50%-99.47%

Lead Time

3-8 Days After Payment

Certification

CE, Doc, ISO, Who(in Application)

When to Test

Early Stage of Infection

Symptoms

Fever, Cough, Fatigue, Shortness of Breath

Test Time

10-15 Minutes

Sample

Nasal Swab

Storage

4-30 Degree

Main Market

Europe

Transport Package

Carton or Customized Package

Specification

20 tests/box, 1 test/box

Trademark

Singclean or Customized brand

Origin

China

HS Code

3002150050

Production Capacity

1 Million PCS/Week

Key features

High Accuracy Rates: Sensitivity 95.87%-99.51%, Specificity 97.18%-99.67%, Accuracy 97.50%-99.47%

Rapid Results: Get qualitative detection results for IgG/IgM antibodies in 10-15 minutes

Multi-Sample Support: Supports detection in whole blood, serum, or plasma using nasal swabs or fingerstick

CE Certified Quality: Approved by CE, ISO, and WHO (in application) with 24-month quality guarantee

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

Fast Lead Time: Delivery within 3-8 days after payment, or within 15 workdays off-season

100% Product Inspection: Every finished product undergoes visual and functional inspection by 66 QA staff

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.