What certifications does the product have?

The product is CE, Doc, and ISO certified.

What is the lead time for production?

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

Antigen/Antibody Test Kit Rapid Diagnostic Test with CE Approved

Name: Antigen/Antibody Test Kit Rapid Diagnostic Test with CE Approved
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 947258865

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

Sensitivity

95.87%-99.51%

Model NO.

test strip & test tube

Specificity

97.18%-99.67%

Accuracy

97.50%-99.47%

Certification

CE, Doc, ISO

Test Time

10-15 Minutes

Sample

Nasopharyngeal Sample & Blood Test

Storage

4-30 Degree

Symptoms

Fever, Cough, Fatigue, Shortness of Breath

Shelf Life

24 Months

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

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

Rapid Result Delivery: Get results in 10-15 minutes using colloidal gold method

CE & ISO Certified: Approved by CE, Doc, and ISO standards for safety and quality

Versatile Sample Types: Compatible with nasopharyngeal samples, whole blood, serum, and plasma

Full Customization Available: ODM and OEM services offered with full customization options

Comprehensive Package Contents: Includes test kits, swabs, extraction tubes, buffers, and lancets

Long Shelf Life: Valid for 24 months when stored properly in sealed pouches

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: ≤4.89h

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.