What is the shelf life of the test kit?

The test kit has a shelf life of 24 months when stored correctly at room temperature.

Strep a Rapid Test Medical Device Infectious Disease Diagnostic Kit

Name: Strep a Rapid Test Medical Device Infectious Disease Diagnostic Kit
Brand: Henan Season Medical Device Co., Ltd.
SKU: 1917483706

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-005

Specimen

Nasal

Ready Time

5mins

Power Source

Manual

Shelf Life

24 Months

Storage

Room Temperature 4-30

Certificate

CE, ISO13485

Transport Package

Carton

Specification

Cassette

Trademark

Origin

Guangzhou

HS Code

3822190090

Production Capacity

5000000pieces/Year

Key features

Fast & Reliable Results: Obtain accurate results in just 4-10 minutes with 96.4% agreement with reference methods.

Comprehensive Kit Contents: Includes sterile swab, tongue depressor, extraction tubes, diluents, and test cassette for immediate use.

CE & ISO13485 Certified: Manufactured under strict quality standards with CE and ISO13485 certifications for safety.

Easy Step-by-Step Procedure: Simple one-step testing process with clear instructions for specimen collection and result reading.

Clear Result Interpretation: Distinct positive, negative, and invalid indicators ensure accurate diagnosis and next steps.

Manual Operation: No power source required; operates manually for convenient use in various settings.

Global Shipping Available: Exported worldwide with flexible terms including FOB, CIF, and DDP for international buyers.

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.