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Ivd Reagent Tsh Thyroid-Stimulating Hormone Test at Home
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

Available

Type

IVD Reagent

Accuracy

98.2%

Model NO.

ST-1006

Format

Cassettes

Product Name

Thyroid Stimulating Hormone Test

Specificity

98.2%

Sensitivity

98.1%

Usage

Home Use and Clinical Use

Transport Package

Carton

Trademark

SD

Origin

Hangzhou

HS Code

3822190090

Production Capacity

300000PCS/Day

Key features

High Accuracy: Accuracy rate exceeds 98.2% for reliable thyroid testing results.
Fast Results: Read results in just 10 minutes with no waiting time.
Home Use Friendly: Designed for laymen to perform easily and confidentially at home.
OEM Service: Customized branding available with a 20-day lead time.
Certified Quality: CE and ISO13485 certified for medical device standards.
Minimal Sample Required: Uses fingerstick whole blood with no extra materials needed.
Versatile Usage: Suitable for both home screening and clinical diagnosis.

Company profile

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤5.91hTerms 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 the accuracy of the TSH test?
A:
The test has an accuracy of more than 98.2%, with a sensitivity of 98.1% and specificity of 98.2%.
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:Is this test suitable for home use?
A:
Yes, it is designed for home use and can be performed by laymen without professional training.
Q:Can I customize the product with my brand?
A:
Yes, OEM service is available with a lead time of 20 days.
Q:What sample type is required?
A:
The test requires a small drop of whole blood obtained via fingerstick.

Send Inquiry

*To:Henan Season Medical Device Co., Ltd.Henan Season Medical Device Co., Ltd.
*Content:
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Supplier replies will be sent to your registered email

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