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Notified Body CE Singclean Nasal Antigen Test Kit for Self Testing
US$1.00-1.80
1,000 Pieces
Product profile
Customization
AvailableType
IVD ReagentMaterial
PlasticModel NO.
CassetteQuality Guarante
2 YearsSensitivity
92.15%-99.05%Specificity
97.47%-99.61%Accuracy
97.19%-99.33%Lead Time
3-8 Days After PaymentCertification
CE, Doc, ISO, Who(in Application)When to Test
Early Stage of InfectionSymptoms
Fever, Cough, Fatigue, Shortness of BreathTest Time
10-15 MinutesSample
Nasal SwabStorage
4-30 DegreeMain Market
EuropeTransport Package
Carton or Customized PackageSpecification
20 tests/box, 1 test/boxTrademark
Singclean or Customized brandOrigin
ChinaHS Code
3002150050Production Capacity
1 Million PCS/WeekKey features
Rapid Self-Testing: Results ready in 15 minutes for early stage infection detection.
High Accuracy: Accuracy ranges from 97.19% to 99.33% with 92.15%-99.05% sensitivity.
CE Certified: Notified Body CE certification for reliable diagnostic performance.
No Instrument Needed: Affordable and portable, requires no additional equipment for use.
Full Customization: ODM and OEM services available for full product customization.
Fast Delivery: Lead time of 3-8 days after payment during off-peak seasons.
2-Year Quality Guarantee: Comprehensive quality assurance covering 2 years for the product.
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: ≤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.
Product Q&A
Q:When should I have a test?
A:
You should test if you experience fever, fatigue, cough, or shortness of breath.
Q:How long does it take to get results?
A:
Results are ready in 15 minutes using the colloidal gold method.
Q:Is this test accurate?
A:
Yes, it offers high accuracy (97.19%-99.33%), sensitivity (92.15%-99.05%), and specificity (97.47%-99.61%).
Q:What is the minimum order quantity?
A:
The minimum order quantity is 10 pieces.
Q:Can I customize the product?
A:
Yes, full customization is available including OEM and ODM services.
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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