Who should conduct the test?

The test is designed for home use. However, for users aged 13-18 years, the test should be conducted by a parent or legal guardian.

Home Use Ivd One-Step Rapid Syphilis Test Kits Europe

Name: Home Use Ivd One-Step Rapid Syphilis Test Kits Europe
Brand: Henan Season Medical Device Co., Ltd.
SKU: 2113316032

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-028

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 and Sensitivity: Achieves 99.9% sensitivity and 99.9% accuracy for reliable detection of Treponema pallidum antibodies.

Rapid Home Testing: Provides preliminary results in just 5 minutes using fingertip blood samples at home.

IVDR and CE Certified: Meets European regulatory standards with IVDR, CE, and ISO certifications for quality assurance.

Easy Cassette Format: Designed as a manual, qualitative cassette test suitable for users aged 13 and above.

Targeted for Specific Groups: Specifically designed for middle-aged and elderly populations to aid in early diagnosis.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤6.13hTerms 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 that can lead to serious health problems if untreated. Symptoms vary by stage: primary, secondary, latent, or tertiary.

Q:How is Syphilis transmitted?

Syphilis is usually passed on through vaginal, anal, or oral sex without a condom. It can also be transmitted through direct contact with skin or tissues of an infected person, and from mother to baby during pregnancy.

Q:What are the symptoms of Syphilis?

Many people have no noticeable symptoms. Primary stage includes a red lump or sore (chancre) and swollen glands. Secondary stage may cause a rash, flu-like illness, mouth sores, and hair loss. Tertiary stage can affect the heart, brain, and nervous system, potentially being life-threatening.

Q:Why do I need a Syphilis home test?

Early detection is crucial to prevent irreversible damage to the heart, blood vessels, and brain. The home test is a quick, easy auxiliary screening tool that takes only 5 minutes, allowing you to test at home anytime.

Q:What do the test results mean?

A negative result means you probably do not have a syphilis infection, though antibodies may take weeks to develop. A positive result indicates antibodies that may be from an infection and requires a follow-up test for confirmation.