Who should conduct the test for users aged 13-18?

For users aged 13-18, the test should be conducted by a parent or legal guardian.

How long does the test take?

The test takes only 5 minutes to complete and provides quick results.

CE Mark One Step Diagnostic Syphilis Self Test Kits Pharmacy

Name: CE Mark One Step Diagnostic Syphilis Self Test Kits Pharmacy
Brand: Henan Season Medical Device Co., Ltd.
SKU: 2116583892

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-108

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.

Quick Home Testing: Results available in just 5 minutes with easy operation.

CE and IVDR Certified: Meets strict European standards for in vitro diagnostic devices.

Minimal Sample Required: Uses fingertip blood for convenient and less invasive testing.

Versatile Usage: Suitable for both pharmacy and home use settings.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤5.53hTerms 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 chancre and swollen glands; Secondary features a rash 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, especially in later stages. The test is quick, easy, and allows for private screening at home.

Q:What do the test results mean?

Negative means no infection detected, but retesting may be needed if exposure occurred recently. Positive indicates antibodies and requires confirmation by a professional.