What is the lead time for orders?

The average lead time is within 15 workdays for both peak and off-peak seasons.

Strep a Group a Streptococcal Antigen Test for Home Use Pharmacy

Name: Strep a Group a Streptococcal Antigen Test for Home Use Pharmacy
Brand: Henan Season Medical Device Co., Ltd.
SKU: 2008799442

Henan, ChinaHenan Season Medical Device Co., Ltd.

US$1.70

10,000-49,999 Sets

US$1.60

50,000-99,999 Sets

US$1.50

100,000+ Sets

Sample price:US$0.50/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Material

Plastic

Model NO.

ST-009

Specimen

Nasal

Ready Time

5mins

Power Source

Manual

Shelf Life

24 Months

Storage

Room Temperature 4-30

Certificate

CE, ISO13485

Product Name

Strep a Home Test

Transport Package

Carton

Specification

Cassette

Trademark

Origin

Guangzhou

HS Code

3822190090

Production Capacity

5000000pieces/Year

Key features

Rapid Results: Provides reliable results in just 4 minutes.

High Accuracy: Overall agreement of 96.4% with reference method.

Home Use Design: Specific immunological test designed for home pharmacy use.

CE & ISO Certified: Product holds CE and ISO13485 certificates.

Long Shelf Life: Valid for 24 months when stored at room temperature.

Complete Kit: Includes swab, tongue depressor, buffers, and test cassette.

Clear Instructions: Step-by-step guide for specimen collection and testing.

Manual Operation: No power source required; operates manually.

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:How long does it take to get results?

You can get quick and reliable results in just 4 minutes.

Q:What is included in the test pack?

The pack contains instructions, a sterile swab, tongue depressor, workstation, extraction tube, two diluent vials, and a sealed test strip with desiccant.

Q:How do I read the test results?

Positive shows two bands (T and C), negative shows only the C band, and invalid shows no bands or only the T band.

Q:What happens if the result is positive?

A positive result indicates Group A strep presence; you should consult a physician for antibiotic treatment.

Q:Can I read results after 15 minutes?

No, do not read results after 15 minutes as the accuracy may be compromised.