What is the lead time for production?

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

What samples can be used for testing?

Nasopharyngeal swabs, whole blood, serum, or plasma can be used.

CE ISO 13485 Singclean Test with Single Swab Individual Buffer

Name: CE ISO 13485 Singclean Test with Single Swab Individual Buffer
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 938553575

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.70-2.70

1,200 Pieces

Sample price:US$3.00/piece.Request sample

Product profile

Customization

Available

Use

Detection for Antigen in Human Body

Speciems

Nasopharyngeal or Throat Swabs

Packing

Sealed Pouch and Carton

Feature

High Sensitivity and Specificity

Shelf Life

2 Years

Sentitivity

88.89%

Specificity

97.87%

Accuracy

94.17%

Transport Package

Carton or Customized Package

Trademark

Singclean or Customized brand

Origin

China

HS Code

3002150090

Production Capacity

300000/Day

Key features

Rapid Result Time: Get results in just 15 minutes for quick diagnosis.

High Accuracy: Accuracy of 94.17% with 88.89% sensitivity and 97.87% specificity.

Long Shelf Life: Valid for 2 years when stored at room temperature or refrigerated.

CE and ISO Certified: Complies with CE, ISO, and ISO 13485 standards for quality assurance.

Full Customization: Offers full customization options for packaging and branding.

Versatile Sample Types: Detects IgG/IgM antibodies in whole blood, serum, or plasma.

OEM and ODM Services: Available OEM and ODM services with 22 R&D engineers.

100% Quality Inspection: Every finished product undergoes visual and functional 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: ≤3.45h

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.