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Product profile
Customization
AvailableType
IVD ReagentCertificates
CE; ISO 13485; FscModel NO.
IVDShipment
by Air or by SeaFeature 1
Fast Results in 10-15 MinutesFeature 2
Over 95% Sensitivity and SpecificityFeature 3
Have Stock, Ready to ShipTransport Package
Carton or Customized PackageSpecification
1 test/box; 20 test/box; 600pcs/cartonTrademark
SingcleanOrigin
ChinaHS Code
3002190000Production Capacity
1000000PCS/MonthKey features
Rapid Results: Obtain qualitative results for IgG and IgM antibodies within 10-15 minutes.
High Accuracy: Ensures over 95% sensitivity and specificity for reliable detection.
Ready to Ship: Inventory available for immediate dispatch upon order confirmation.
Certified Quality: Manufactured under CE, ISO 13485, and FSC standards.
Versatile Testing: Detects antibodies in whole blood, serum, or plasma samples.
Full Customization: Offers full customization options for OEM and ODM services.
Comprehensive Kit: Includes all necessary components like swabs, buffers, and lancets.
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: ≤4.96h
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 IgG/IgM test?
A:
The test provides rapid results within 10-15 minutes.
Q:What is the sensitivity and specificity of this kit?
A:
The kit ensures over 95% sensitivity and specificity.
Q:What samples can be used for testing?
A:
It detects antibodies in human whole blood, serum, or plasma.
Q:Is customization available for this product?
A:
Yes, full customization options including OEM and ODM are available.
Q:What is the minimum order quantity?
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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