Identity
- Trade Name
- Validate FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
- Device Name
- Validate TDM1bc is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. FDA UDI
- Model / Reference
- 301bc FDA UDI
- Description
- Validate TDM1bc is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. FDA UDI
Identifiers
- Catalog Number
- 301bc FDA UDI
- Primary DI / UDI-DI
- 00859110005029 FDA UDI
- FDA Product Code
- DKB FDA UDI
- GMDN Term
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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
No
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
Validate by LGC Clinical Diagnostics, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI e2c91027-6d30-427a-bee5-bc0d6046ace0 37 fields · synced Jun 9, 2026