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Singclean Ivd Reagent Monkeypox Igg/Igm Antibody Test Kit Diagnostic with CE
US$3.00-3.40
1,000 Pieces
Product profile
Customization
AvailableType
IVD ReagentShelf Life
1 YearStorage Condition
4° C to 30°cTransport Package
Box, CartonSpecification
1test/box, 5tests/box, 20 tests/boxTrademark
SingcleanOrigin
Hangzhou, ChinaProduction Capacity
50000/DayKey features
CE Certified IVD Reagent: Singclean Monkeypox IgG/IgM Test Kit with CE certification for reliable diagnostic use.
Rapid Immunochromatography: Solid phase immuno-chromatographic assay for rapid qualitative detection of antibodies.
High Sensitivity Detection: Detects both IgG and IgM antibodies to Monkeypox virus in human blood samples.
Flexible Packaging Options: Available in 1, 5, or 20 tests per box to suit different laboratory needs.
Comprehensive Quality Control: Features an internal control line (C) to ensure test validity and proper chromatography.
OEM/ODM Customization: Full customization options available with OEM and ODM services supported.
Professional Manufacturer: Established in 2003 with ISO9001:2015 certification and 66 QA/QC inspectors.
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: ≤5.01h
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 sample types can be tested?
A:
The kit is designed for qualitative detection of antibodies in human blood, including serum, plasma, and whole blood specimens.
Q:How long does the test take to get results?
A:
Results should be read at 10 minutes. Do not interpret results after 15 minutes to ensure accuracy.
Q:Is this test kit CE certified?
A:
Yes, the Singclean Monkeypox IgG/IgM Test Kit is an IVD reagent with CE certification.
Q:What is the Minimum Order Quantity (MOQ)?
A:
The Minimum Order Quantity is 10 PCS.
Q:Does the manufacturer offer customization services?
A:
Yes, OEM and ODM services are available with full customization options.
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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