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Product profile
Customization
AvailableType
IVD ReagentCertificates
CE; ISO 13485; FscModel NO.
test strip & test tubeShipment
by Air or by SeaFeature 1
Fast Results in 10-15 MinutesFeature 2
Have Stock, Ready to ShipSensitivity
95.87%-99.57%Specificity
97.18%-99.67%Accuracy
97.50%-99.47%Transport Package
Carton or Customized PackageSpecification
1 test/box; 20 test/box; 600pcs/cartonTrademark
SingcleanOrigin
ChinaHS Code
3002190000Production Capacity
80000PCS/Day; 500000PCS/Week; 15000000PCS/YearKey features
Rapid Results: Obtain qualitative IgG/IgM antibody results in just 10-15 minutes.
High Accuracy: Sensitivity up to 99.57% and specificity up to 99.67% for reliable detection.
Ready Stock: Inventory available for immediate shipment via air or sea.
Certified Quality: Products hold CE and ISO 13485 certifications for safety and compliance.
Customizable: Full customization options available for OEM and ODM services.
Versatile Sampling: Supports detection in whole blood, serum, or plasma samples.
Manufacturer Direct: Direct supply from a certified factory with 22 R&D engineers.
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: ≤3.77h
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 this test kit?
A:
The test provides rapid results, typically within 10-15 minutes.
Q:What is the sensitivity and specificity of the test?
A:
The test features high sensitivity (95.87%-99.57%) and specificity (97.18%-99.67%).
Q:What types of samples can be used?
A:
The kit is designed for qualitative detection in human whole blood, serum, or plasma.
Q:Is customization available for this product?
A:
Yes, full customization options are available, including OEM and ODM services.
Q:What is the minimum order quantity (MOQ)?
A:
The minimum order quantity is 10 PCS.
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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