VALIDATE® THY Test Set
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Basic Information
- Primary DI
- 00850011135174
- Basic UDI-DI Code
- B-00850011135174
- Reference
- 901bc
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE THY Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi automated, and manual instrument systems for the following analytes: THY Set: cortisol (COR), triiodothyronine (T3), thyroxine (T4) and human thyroid stimulating hormone (TSH). FT4 Set: free thyroxine (FT4). The THY Set also contains free triiodothyronine (FT3) as an element of the Total T3 component.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152002 | HORMONE CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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