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Fast Result Igm/Igg Rapid Test Kit with CE, Read Test 2-15 Minutes
US$1.50-4.50
10,000 Pieces
Sample price:US$10.00/piece.Request sample
Product profile
Customization
AvailableClassification
Biological DiagnosticsCertification
CE, ISO13485, White ListType
Antibody TestGroup
AllModel No.
Cassette/Strip/DeviceSpeciems
Human Wholeblood, Serum or Plasma.Packing
Box and CartonFeature 1
Fast Results in 2-15 MinutesFeature 2
One Step Disinfection Tablets and LancetsFeature 3
High Sensitivity and SpecificityTransport Package
by Air or by SeaSpecification
1 test/box; 20 test/box;Trademark
SingcleanOrigin
ChinaHS Code
3002190000Key features
Rapid 2-15 Min Results: Provides qualitative detection of IgG/IgM antibodies in just 10-15 minutes for fast diagnosis.
High Sensitivity & Specificity: Ensures accurate differential detection of antibodies with minimal false positives or negatives.
Complete Kit with Accessories: Includes test cassette, dropper, desiccant, buffer, alcohol pad, and lancet for immediate use.
No Equipment Required: Simple one-step procedure with all necessary reagents provided; no centrifuge or lab tools needed.
CE & ISO13485 Certified: Meets international standards for quality and safety with CE, ISO13485, and White List certifications.
Full Customization Available: Offers OEM and ODM services with full customization options for branding and packaging.
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: ≤4.62h
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 testing time for this kit?
A:
The test provides fast results in 2-15 minutes, allowing for rapid diagnosis and on-site screening.
Q:Are all necessary materials included in the kit?
A:
Yes, each sealed pouch contains a test cassette, dropper, desiccant, buffer, alcohol pad, and lancet. No additional equipment is required.
Q:Is this test for professional use only?
A:
Yes, it is for professional In Vitro diagnostic use only. Users must read the package insert completely before performing the test.
Q:What certifications does the product have?
A:
The product holds CE, ISO13485, and White List certifications, ensuring compliance with international quality and safety standards.
Q:Can the product be customized?
A:
Yes, full customization is available. The manufacturer offers OEM and ODM services to meet specific branding and packaging needs.
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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