Identity
- Trade Name
- Free Phenytoin Controls FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
- Model / Reference
- 20759023322 FDA UDI
Identifiers
- Catalog Number
- 20759023322 FDA UDI
- Primary DI / UDI-DI
- 04015630915828 FDA UDI
- 510(k) Number
- K954992 FDA UDI
- FDA Product Code
- MOJ FDA UDI
- GMDN Term
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3350 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: Multiple therapeutic drugs/drugs of abuse IVD, control
Free Phenytoin Controls by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple therapeutic drugs/drugs of abuse IVD, control.
- ALPRAZOLAM PLUS CALIBRATOR LEVEL 3 — UTAK LABORATORIES, INC. · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- OPIATES CALIBRATOR LEVEL 5 — UTAK LABORATORIES, INC. · Class I
- BLANK HAIR MATRIX — UTAK LABORATORIES, INC. · Class I
- DRUGS OF ABUSE LEVEL 1 — UTAK LABORATORIES, INC. · Class I
- PSYCH QC 3 V3 — UTAK LABORATORIES, INC. · Class I
- URINE QC HIGH — UTAK LABORATORIES, INC. · Class I
- URINE QC HIGH — UTAK LABORATORIES, INC. · Class I
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.
- Lidocaine — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 8fdc8295-e96d-4699-96e0-be98ba0c1ba3 34 fields · synced May 30, 2026