What certifications does the product have?

The product holds CE and ISO 13485 certifications.

What is the shelf life?

The shelf life is 2 years when stored properly.

AG Cassette Rapid Test

Name: AG Cassette Rapid Test
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 936783795

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-2.50

1,200 Pieces

Sample price:US$2.50/piece.Request sample

Product profile

Customization

Available

Use

Detection for New Pneumonia Virus

Speciems

Nasal/Throat Swabs for, Wb/S/P for Igg Igm

Model NO.

IVD

Packing

Sealed Pouch and Carton

Feature

High Sensitivity and Specificity

Shelf Life

2 Years

Sentitivity

Antibody 95.1% 88.89%

Specificity

Antibody 98.5% 97.87%

Average Accuracy

95%

Certificate

CE; ISO 13485; Fsc

Transport Package

Carton or Customized Package

Trademark

Singclean or Customized brand

Origin

China

HS Code

3002150090

Production Capacity

30000/Day

Key features

High Accuracy: Average accuracy of 95% with antibody sensitivity of 95.1% and specificity of 98.5%.

Rapid Results: Get qualitative and differential detection results for IgG and IgM antibodies in just 15 minutes.

Multi-Sample Support: Compatible with human whole blood, serum, plasma, nasal swabs, and throat swabs.

Certified Quality: Holds CE and ISO 13485 certifications ensuring reliable medical diagnostic standards.

Full Customization: Offers full customization options for OEM and ODM services to meet specific needs.

Comprehensive Kit: Includes test cassettes, swabs, extraction tubes, droppers, and buffer for immediate use.

Factory Direct: Manufactured by a certified 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: ≤5.19h

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.