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Ivd Reagent Blood Antibody Test Syphilis Self Testing
US$1.50
1,000-9,999 Pieces
US$1.40
10,000-99,999 Pieces
US$1.20
100,000+ Pieces
Sample price:US$0.00/piece.Request sample
Product profile
Customization
AvailableType
IVD ReagentProduct Name
Syphilis Home TestModel NO.
SY-137Sensitivity
99.9%Accuarcy
99.9%Specimen
Fingertip BloodShelf Life
24 MonthsUsage
Home UseTest Result
in 5 MinutesStorage
2-30 DegreePacakge
1 Test/BoxTransport Package
CartonSpecification
CassetteTrademark
SDOrigin
ChinaHS Code
3822190090Production Capacity
300000PCS/DayKey features
High Accuracy Rate: Achieves 99.9% sensitivity and 99.9% accuracy for reliable results.
Rapid Result Time: Provides test results in just 5 minutes for quick screening.
Home Use Convenience: Designed for easy self-testing at home using fingertip blood samples.
Regulatory Compliance: Certified with IVDR CE and ISO standards for quality assurance.
Long Shelf Life: Ensures product stability and usability for 24 months.
Easy Storage Conditions: Can be stored at room temperature between 2-30 degrees Celsius.
Preliminary Screening Tool: Serves as an auxiliary screening tool for early detection of syphilis.
Cassette Format: Utilizes a cassette format for straightforward qualitative testing.
Company profile
Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤4.00hTerms of Payment: T/T, PayPal, Western Union, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, DDP, DAP, FCA
AI-Powered supplier vetting
SummaryHenan Season Medical Device Co., Ltd. is identified as a Chinese manufacturer/factory specializing in point-of-care and in-vitro diagnostic self-testing products. The supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and lead times of within 15 working days in both peak and off-peak seasons. Its stated export coverage is broad, with exports accounting for 90% of total sales. ISO 9001, ISO 13485, ISO 14001, and CE/FDA-related approvals are reported. Evidence also indicates OEM packaging, R&D engineers, and quality-control staff. However, the provided information does not sufficiently establish after-sales service processes, financial credibility, or verified customer case depth. Trade data shows only one transaction, which is insufficient to demonstrate an established customer track record.
Supplier typeThe supplier is explicitly identified as a Manufacturer/Factory and Limited Company based in Zhengzhou, Henan, China. Its stated business focuses on biomedical IVD and rapid self-testing products, indicating direct manufacturing involvement rather than only trading activity.
CertificationsThe supplier reports ISO 9001, ISO 13485, and ISO 14001 certifications or approvals, and states that its products have received CE approval in Europe and FDA approval in the United States. These claims provide explicit evidence of a certification and regulatory-compliance capability, although the slices do not provide certificate numbers, validity dates, or scope details.
R&D capabilityThe supplier reports 6–10 years of R&D engineer experience and offers a broad range of rapid and self-testing products, including digital pregnancy and ovulation tests, vitamin D, UTI, syphilis, and drug tests. This supports product-development capability, although no specific patents, new-product launches, or measurable innovation outcomes are provided.
Production capacityThe supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and order fulfillment within 15 working days during both peak and off-peak seasons. Its export sales share is reported as 90%, indicating stated production and international fulfillment experience.
Customization capabilityThe supplier explicitly offers OEM packaging and states that it provides customer-specific solutions and configurations. This supports packaging-level customization, but the slices do not confirm broader customization such as formulation, tooling, labeling compliance, or product design changes.
Product Q&A
Q:What is the accuracy of the Syphilis Self Test?
A:
The test has a sensitivity of 99.9% and an accuracy of 99.9%.
Q:How long does it take to get results?
A:
You can get test results in just 5 minutes.
Q:What type of sample is required for the test?
A:
The test requires a fingertip blood sample.
Q:What does a negative result mean?
A:
A negative result means you probably do not have a syphilis infection, but antibodies may take weeks to develop after exposure.
Q:What does a positive result indicate?
A:
A positive result means you have antibodies that may be from a syphilis infection, and you need another test to confirm.
Send Inquiry
*To:Henan Season Medical Device Co., Ltd.
Henan Season Medical Device Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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