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CE Certified Rapid Diagnostic Test Kit Antibody Igm Igg Swab Test

Name: CE Certified Rapid Diagnostic Test Kit Antibody Igm Igg Swab Test
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 937131835

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-3.00

2,000 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Sensitivity

95.87%-99.51%

Specificity

97.18%-99.67%

Accuracy

97.50%-99.47%

Method

Colloidal Gold Method

Applicant

Fever, Cough, Shortness of Breath

Format

Cassette

Storage

4-30c Degree

Transportation

by Air

Time

10 Minutes

Transport Package

20PCS/Box, 600PCS/CTN

Specification

1 test/box; 20 test/box; Uncut sheet

Trademark

Singclean

Origin

China

HS Code

3002150090

Production Capacity

100 0000PCS/Month

Key features

CE Certified Diagnostic Kit: Validates safety and efficacy for rapid IgG/IgM antibody detection in blood or plasma.

High Accuracy & Sensitivity: Achieves 95.87%-99.51% sensitivity and 97.18%-99.67% specificity via Colloidal Gold Method.

Rapid Result Delivery: Provides qualitative differential detection results within 10 to 15 minutes.

Flexible Customization: Offers full customization options including OEM and ODM services for tailored solutions.

Comprehensive Package Contents: Includes swabs, extraction tubes, buffers, lancets, and detailed instructions for easy use.

Verified Quality Control: 100% finished product inspection by 66 QA/QC inspectors ensures consistent high quality.

Manufacturer Direct Supply: Established in 2003 with 546 employees, ISO9001:2015 certified, and 10 production lines.

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: ≤3.90h

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.