Auraflex Tsh-3 200 Test Pack Model Number 80600, Auraflex Tsh-3 Calibrator Pack Model Number Number 80601 Auraflex DIL0
510(k) K980574
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980574 | Date24 Mar 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JLW
- FDA applicant
- Alfa Biotech (Uk) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1690
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
Auraflex TSH-3 is a third-generation fluorescent enzyme immunoassay that performs quantitative TSH measurement in human serum or plasma. It is a radioimmunoassay device for thyroid-stimulating hormone, classified under clinical chemistry.
It is used in clinical laboratory settings and operated by laboratory technicians. The device is supplied as a test pack and calibrator pack with model numbers 80600 and 80601, and includes Auraflex Dil0. It received FDA 510(k) clearance under K980574 on March 24, 1998, and is classified as a Class II device.
Other devices from Alfa Biotech (Uk), Ltd.
Questions
AI-generated answers, 26 Sep 2026
What is the Auraflex TSH-3 used for?
The Auraflex TSH-3 is used for quantitative measurement of thyroid-stimulating hormone (TSH) in human serum or plasma. It is a third-generation fluorescent enzyme immunoassay designed for use in clinical laboratory settings by laboratory technicians to assess thyroid function.
How is the Auraflex TSH-3 supplied and what does it include?
The Auraflex TSH-3 is supplied as a test pack (model number 80600) and a calibrator pack (model number 80601), and includes Auraflex Dil0. These components are intended for use together to perform TSH measurements in clinical laboratories.
Is the Auraflex TSH-3 a single-use or reusable device?
The Auraflex TSH-3 test and calibrator packs are intended for single-use in clinical laboratory procedures. Each pack contains reagents and materials designed for one testing cycle, and reuse is not supported by the device's design or intended use as described in the labeling.