VALIDATE® TDM1 Test Set
Basic Information
- Primary DI
- 00859110005012
- Basic UDI-DI Code
- B-00859110005012
- Reference
- 301au
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE TDM1 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: acetaminophen (ACTM), amikacin (AMIK), carbamazepine (CARB), digoxin (DIGN), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), Phenobarbital (PHNO), phenytoin (PHYT), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SALY), theophylline (THEO), tobramycin (TOB), valproic acid (VALP) and vancomycin (VANC).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102152001 | TDM/DRUG CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).