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THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
- Device Name
- Therapeutic Drug Markers (TDM) Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid and Vancomycin assays. FDA UDI
- Model / Reference
- LV10355 FDA UDI
- Description
- Therapeutic Drug Markers (TDM) Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid and Vancomycin assays. FDA UDI
Identifiers
- Catalog Number
- LV10355 FDA UDI
- Primary DI / UDI-DI
- 05055273216264 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple therapeutic drugs/drugs of abuse IVD, control
THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 9b40315a-61ee-4779-8a47-1720601ee09d 36 fields · synced May 30, 2026