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Antibody/Igg/Igm Rapid Diagnostic Test Kit with CE, Fast Result
US$1.50-4.50
10,000 Pieces
Sample price:US$10.00/piece.Request sample
Product profile
Customization
AvailableClassification
Biological DiagnosticsCertification
CE, ISO13485Type
Antibody TestModel 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;Origin
ChinaHS Code
3002190000Key features
Fast Result Time: Provides results within 2-15 minutes for rapid diagnosis.
High Sensitivity: Ensures accurate and reliable qualitative detection of IgG and IgM antibodies.
CE and ISO13485 Certified: Meets international safety and quality standards for medical diagnostics.
Full Customization: Offers OEM and ODM services with full customization options available.
Simple One-Step Operation: Easy to use with included disinfection tablets and lancets for immediate testing.
Versatile Sample Types: Compatible with human whole blood, serum, or plasma for diverse testing needs.
Complete Kit Package: Includes test kits, swabs, extraction tubes, buffers, and lancets for immediate use.
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: ≤4.91h
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:How long does it take to get results?
A:
You can get results in 2 to 15 minutes.
Q:What sample types are supported?
A:
The kit supports human whole blood, serum, or plasma.
Q:Is the product customizable?
A:
Yes, full customization including OEM and ODM services is available.
Q:What certifications does the kit have?
A:
The kit is certified with CE and ISO13485.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 10 pieces.
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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