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Virus Novel Antigen Rapid Kits Test for Influenza
Negotiable
500 Pieces
Sample price:US$1.20/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Reference

in Vitro Diagnostic Directive (98/79/Ec)

Certificate

ISO13485, CE, ISO9001

Classification

Ivdd Others

Relative Sensitivity

96%

Relative Specificity

98%

Accuracy

97%

Specimen

Saliva

Transport Package

500test/Carton; 600test/Carton

Specification

1 test/box; 20 test/box; 50 test/box

Trademark

Singclean

Origin

China, Hangzhou

HS Code

3002150090

Production Capacity

50000/Day

Key features

Rapid 15-Minute Results: Provides qualitative detection results in just 15 minutes without requiring instruments.
High Diagnostic Accuracy: Features 96% relative sensitivity, 98% relative specificity, and 97% accuracy for reliable detection.
Saliva Specimen Testing: Designed for non-invasive antigen detection using human saliva samples via colloidal gold method.
Full Customization Available: Offers full customization options including OEM and ODM services for tailored product needs.
ISO and CE Certified: Manufactured under ISO13485, CE, and ISO9001 standards ensuring quality and regulatory compliance.
Portable and Affordable: Highly portable diagnostic tool that is affordable and requires no external instruments for operation.
100% Finished Product Inspection: Every unit undergoes 100% visual and functional inspection by 66 dedicated QA/QC inspectors.
Flexible Lead Time: Offers lead times within 15 workdays during off-peak season and one month during peak season.

Company profile

Hangzhou Singclean Medical Products Co., Ltd.
Importers and ExportersExhibition Experience
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: ≤5.01h

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.

Product Q&A

Q:What is the detection time for the test?
A:
Results are ready in 15 minutes, providing a rapid qualitative detection of the virus antigen.
Q:What type of specimen is used for this test?
A:
The test kit is designed for use with human saliva specimens.
Q:Is this test accurate?
A:
Yes, it offers 96% relative sensitivity, 98% relative specificity, and 97% accuracy.
Q:Can I customize the product?
A:
Yes, full customization is available, including OEM and ODM services.
Q:What certifications does the product have?
A:
The product complies with the In Vitro Diagnostic Directive (98/79/Ec) and holds ISO13485, CE, and ISO9001 certifications.

Send Inquiry

*To:Hangzhou Singclean Medical Products Co., Ltd.Hangzhou Singclean Medical Products Co., Ltd.
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