FDA UDI
In Commercial Distribution
🇺🇸 United States
DOA CONTROL 1
DI: 05055273207897
·
Model: DA3121
·
RANDOX LABORATORIES LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DOA CONTROL 1
- Primary DI
- 05055273207897
- Version / Model
- DA3121
- Catalog Number
- DA3121
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2025-05-12
- Public Version Status
- Update
- Public Device Record Key
- d3febb13-225a-4f30-bbdc-ed608f481d37
Device Description
The Randox Multidrug Control Level 1 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates 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
- No
- 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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
| DIF | Drug Mixture Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55461 | Multiple 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 one or multiple 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 | 05055273207897 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stable for 28 days at +2ºC to +8ºC once opened
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius