Identity
- Trade Name
- Lidocaine FDA UDI
- Generic Name
- Lidocaine therapeutic drug monitoring IVD, reagent FDA UDI
- Model / Reference
- 20757241322 FDA UDI
Identifiers
- Catalog Number
- 20757241322 FDA UDI
- Primary DI / UDI-DI
- 04015630915736 FDA UDI
- 510(k) Number
- K954992 FDA UDI
- FDA Product Code
- KLR FDA UDI
- GMDN Term
- Lidocaine therapeutic drug monitoring IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3555 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
No
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: Lidocaine therapeutic drug monitoring IVD, reagent
Lidocaine by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K954992 also covers:
- Antistreptolysin O — Roche Diagnostics Corp.
- COBAS FP Free Phenytoin Calibrators — Roche Diagnostics Corp.
- COBAS FP Free Valproic Acid Calibrators — Roche Diagnostics Corp.
- COBAS Salicylate Calibrator — Roche Diagnostics Corp.
- Free Phenytoin Controls — Roche Diagnostics Corp.
- Magnesium — Roche Diagnostics Corp.
- Magnesium — Roche Diagnostics Corp.
- Methaqualone — Roche Diagnostics Corp.
- Propoxyphene — Roche Diagnostics Corp.
- Salicyclate — Roche Diagnostics Corp.
- Salicylate — Roche Diagnostics Corp.
- Serum proteins T Standard — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI f446e8e1-6f04-4412-a09d-56b90037c955 35 fields · synced May 29, 2026