FDA UDI
In Commercial Distribution
🇺🇸 United States
THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems)
DI: 05055273216264
·
Model: LV10355
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems)
- Primary DI
- 05055273216264
- Version / Model
- LV10355
- Catalog Number
- LV10355
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-05
- Public Version
- 1
- Public Version Date
- 2019-08-13
- Public Version Status
- New
- Public Device Record Key
- 9b40315a-61ee-4779-8a47-1720601ee09d
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DIF | Drug Mixture Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30503 | Multiple therapeutic drugs/drugs of abuse IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273216264 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -70 – -20 Degrees Celsius