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

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

What type of sample is required for this test?

This test is designed to detect Treponema pallidum antibodies in human fingertip blood samples.

New Product Home Use Early Screening Home Testing Syphilis Rapid Test

Name: New Product Home Use Early Screening Home Testing Syphilis Rapid Test
Brand: Henan Season Medical Device Co., Ltd.
SKU: 2114306332

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-065

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

Rapid Home Testing: Quick and easy operation with results available in just 5 minutes for home use.

Minimal Sample Requirement: Designed to detect antibodies using only a small sample of fingertip blood.

Regulatory Compliance: Certified with IVDR, CE, and ISO standards for quality assurance.

Clear Result Interpretation: Provides qualitative results to help users understand their screening status easily.

Suitable for Multiple Stages: Effective screening tool for early detection to prevent serious health complications.

Fast Production Lead Time: Average lead time within 15 workdays for both peak and off-peak seasons.

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 (STI) caused by the bacterium Treponema pallidum subspecies pallidum. It can lead to serious health problems if not treated and cured. Symptoms depend on the 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 passed on from direct contact with the skin or tissues of someone with syphilis. If you are pregnant, it is possible for syphilis to be passed on to the baby.

Q:What are the symptoms of Syphilis?

Many people with syphilis will not have noticeable symptoms. Primary syphilis may include a red lump or firm ulcer (chancre) and swollen glands. Secondary syphilis may include a spotty red rash, flu-like illness, lumps, sores in the mouth, vagina, or anus, and patchy hair loss. Tertiary syphilis is the most serious stage and can affect the heart, blood vessels, brain, and nervous system.

Q:Why do I need a Syphilis home test?

Early detection is crucial because the virus appears on the skin surface in the first stage and is easy to treat. In later stages, it can cause irreversible damage to the heart, blood vessels, and brain. A self-test allows you to screen at home anytime, taking only 5 minutes, to protect your health.

Q:What do the test results mean?

If the screening test result is negative, it means you probably do not have a syphilis infection, but antibodies can take a couple of weeks to develop. If the result is positive, it means you have antibodies that may be from a syphilis infection, and you will need another test to confirm.