Identity
- Trade Name
- DRUG CONTROL - LEVEL 3 (TDM CONTROL 3) FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
- Device Name
- This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision. FDA UDI
- Model / Reference
- HD1669 FDA UDI
- Description
- This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273203592 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
Drug Control - Level 3 (tdm Control 3) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 91e6e887-6768-41c5-a25f-d9124d93a65f 35 fields · synced Jun 8, 2026