What is the lead time for production?

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

How accurate is the test?

The test demonstrates high accuracy with sensitivity up to 99.51%, specificity up to 99.67%, and accuracy up to 99.47%.

Rapid Diagnostic Test with CE Marked Antigen/Antibody Test

Name: Rapid Diagnostic Test with CE Marked Antigen/Antibody Test
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 947259755

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 Diagnostic Accuracy: Sensitivity 95.87%-99.51%, Specificity 97.18%-99.67%, Accuracy 97.50%-99.47%.

Rapid Result Delivery: Obtain qualitative results for IgG/IgM antibodies in just 10-15 minutes.

Versatile Sample Types: Supports detection using nasopharyngeal samples, whole blood, serum, or plasma.

CE Certified Quality: Product holds CE, Doc, and ISO certifications ensuring regulatory compliance.

Full Customization Support: Offers full customization options including OEM and ODM services for branding.

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

Manufacturer Direct Supply: Direct from factory with 10 production lines and 100% finished product inspection.

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: ≤5.10h

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.