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One Step Strep a Rapid Self Test Pharmacy
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
AvailableType
IVD ReagentMaterial
PlasticModel NO.
ST-008Specimen
NasalReady Time
5minsPower Source
ManualShelf Life
24 MonthsStorage
Room Temperature 4-30Certificate
CE, ISO13485Product Name
Strep a Home TestTransport Package
CartonSpecification
CassetteTrademark
SDOrigin
GuangzhouHS Code
3822190090Production Capacity
5000000pieces/YearKey features
Rapid Results: Provides reliable results in just 4 minutes with 96.4% agreement to reference methods.
Specific Detection: Specifically detects Group A streptococcus bacteria to distinguish from viral infections.
Easy Self-Testing: Simple step-by-step instructions allow for accurate home testing without professional help.
Complete Kit: Includes sterile swab, tongue depressor, extraction tube, buffers, and test cassette.
CE and ISO Certified: Product holds CE and ISO13485 certificates ensuring quality and safety standards.
Long Shelf Life: Valid for 24 months when stored at room temperature between 4-30 degrees Celsius.
Clear Result Reading: Distinct positive, negative, and invalid indicators guide users on next medical steps.
Fast Delivery: Average lead time within 15 workdays for both peak and off-peak seasons.
Company profile
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 symptoms indicate the need for a Strep A test?
A:
Symptoms include sudden severe sore throat, pain swallowing, fever over 101 degrees, and swollen lymph nodes.
Q:How long does it take to get results?
A:
You can read the results after waiting 10 minutes, but do not read them after 15 minutes.
Q:What is included in the test pack?
A:
The pack contains instructions, a sterile swab, tongue depressor, workstation, extraction tube, two buffer vials, and a test strip.
Q:How do I know if the result is positive?
A:
A positive result shows two color bands: one in the test (T) region and one in the control (C) region.
Q:What should I do if the test is invalid?
A:
If no bands appear or only the test band appears, repeat with a new kit or contact the distributor.
Send Inquiry
*To:Henan Season Medical Device Co., Ltd.
Henan Season Medical Device Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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