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One Step Thyroid Rapid Anti Body Test Kits for Home Use
US$1.90
10,000-49,999 Pieces
US$1.80
50,000-99,999 Pieces
US$1.70
100,000+ Pieces
Sample price:US$0.10/piece.Request sample
Product profile
Customization
AvailableType
IVD ReagentAccuracy
98.2%Model NO.
ST-021Format
CassettesProduct Name
Thyroid Stimulating Hormone TestSpecificity
98.2%Sensitivity
98.1%Usage
Home UseCertificate
TUV CE, ISOSpecimen
Whole BloodTransport Package
CartonTrademark
SDOrigin
HangzhouHS Code
3822190090Production Capacity
300000PCS/DayKey features
High Accuracy & Sensitivity: Sensitivity 98.1% and Specificity 98.2% for reliable thyroid function monitoring.
Rapid Home Use Results: Read results in just 10 minutes using a simple fingerstick whole blood test.
Easy Layman Operation: Designed for privacy and convenience, no other materials required for testing.
Certified Quality Standards: Holds TUV CE and ISO13485 certificates ensuring safety and efficacy.
Flexible OEM Service: OEM customization available with a lead time of only 20 days.
Long Shelf Life: Stable product with a shelf time of 24-36 months for convenient storage.
Company profile

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤8.66hTerms 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?
A:
You can read the results at 10 minutes. Do not interpret the result after 20 minutes.
Q:What type of sample is required?
A:
The test uses a fingerstick whole blood protocol. No other materials are required.
Q:How do I interpret the test results?
A:
POSITIVE: Two colored lines (T and C) appear. NEGATIVE: One colored line (C) appears. INVALID: Control line fails to appear.
Q:Is OEM service available for this product?
A:
Yes, OEM customization is available with an OEM time of 20 days.
Q:What certifications does the product have?
A:
The product holds TUV CE and ISO13485 certificates.
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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