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CE Marked Antigen AG Swab Saliva Rapid Test Card
Negotiable
500 Pieces
Sample price:US$1.20/piece.Request sample
Product profile
Customization
AvailableType
IVD ReagentReference
in Vitro Diagnostic Directive (98/79/Ec)Certificate
ISO13485, CE, ISO9001Classification
Ivdd OthersRelative Sensitivity
96%Relative Specificity
98%Accuracy
97%Transport Package
500test/Carton; 600test/CartonSpecification
1 test/box; 20 test/box; 50 test/boxTrademark
SingcleanOrigin
China, HangzhouHS Code
3002150090Production Capacity
50000/DayKey features
Rapid 15-Minute Results: Provides accurate diagnostic results for active infection in just 15 minutes.
CE Marked & Certified: Certified under ISO13485, CE, and ISO9001 standards for in vitro diagnostics.
High Accuracy Rate: Features 97% accuracy, 96% relative sensitivity, and 98% relative specificity.
No Instrument Required: Affordable and highly portable self-testing solution without need for equipment.
Full Customization Available: Offers full customization options for ODM and OEM services.
100% Quality Inspection: All finished products undergo visual and functional inspection before shipping.
Global Supply Capability: Manufacturer with 10 production lines and 22 R&D engineers serving global markets.
Company profile
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: ≤4.29h
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 are the symptoms indicating when I should have a test?
A:
You should consider testing if you experience fever, fatigue, cough, or shortness of breath.
Q:How do I interpret the test results?
A:
Negative: Only the C band is present. Positive: Both C and T bands are present. Invalid: Control line fails to appear.
Q:Is this test for self-use?
A:
Yes, this test provides a preliminary result for self-testing. Any reactive specimen must be confirmed with alternative testing methods.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 10 pieces.
Q:Do you offer OEM or ODM services?
A:
Yes, we offer both OEM and ODM services with full customization options available.
Send Inquiry
*To:
Hangzhou Singclean Medical Products Co., Ltd.
Hangzhou Singclean Medical Products Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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