Who should use this test?

It is designed for users 13-18 years of age to be conducted by a parent or legal guardian, and for adults for home use.

How long is the shelf life?

The product has a shelf life of 24 months when stored at temperatures between 2-30 degrees Celsius.

CE Mark One Step Rapid Syphilis Test for Home Use

Name: CE Mark One Step Rapid Syphilis Test for Home Use
Brand: Henan Season Medical Device Co., Ltd.
SKU: 2113291062

Henan, ChinaHenan Season Medical Device Co., Ltd.

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

Available

Type

IVD Reagent

Product Name

Syphilis Self Test

Model NO.

SY-097

Sensitivity

99.9%

Accuarcy

99.9%

Specimen

Fingertip Blood

Shelf Life

24 Months

Usage

Home Use

Transport Package

Carton

Specification

Cassette

Trademark

Origin

China

HS Code

3822190090

Production Capacity

300000PCS/Day

Key features

High Accuracy Rate: 99.9% sensitivity and 99.9% accuracy for reliable detection.

Rapid Results: Get preliminary results in just 5 minutes with simple operation.

Home Use Convenience: Designed for private, self-testing at home without professional help.

CE Certified: Meets IVDR and ISO standards for quality and safety assurance.

Long Shelf Life: Valid for 24 months when stored between 2-30 degrees Celsius.

Minimal Sample Required: Uses fingertip blood for easy and less invasive collection.

Comprehensive Detection: Detects Treponema pallidum antibodies to aid syphilis diagnosis.

Fast Delivery: Peak and off-peak season lead times within 15 working days.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤9.88hTerms 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 Syphilis?

Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum subspecies pallidum that can lead to serious health problems if untreated.

Q:How is Syphilis transmitted?

It is usually passed on through vaginal, anal, or oral sex without a condom, direct contact with skin or tissues, or from mother to baby during pregnancy.

Q:What are the symptoms of Syphilis?

Symptoms vary by stage: Primary includes a red lump or sore; Secondary may cause rashes and flu-like illness; Tertiary can affect the heart, brain, and nervous system.

Q:Why do I need a Syphilis home test?

Early detection prevents irreversible damage. The test is quick, easy, and allows you to screen at home anytime to protect your health.

Q:What do the test results mean?

Negative means you likely don't have an infection, but retest if exposed recently. Positive means you have antibodies and need a confirmatory test.