Identity
- Trade Name
- IMMULITE® 2000 Systems PHN Phenytoin FDA UDI
- Generic Name
- Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Phenytoin - IMMULITE - RGT - 200 Tests FDA UDI
- Model / Reference
- 10381548 FDA UDI
- Description
- Phenytoin - IMMULITE - RGT - 200 Tests FDA UDI
Identifiers
- Catalog Number
- L2KPN2 FDA UDI
- Primary DI / UDI-DI
- 00630414961903 FDA UDI
- 510(k) Number
- K000006 FDA UDI
- FDA Product Code
- DIP FDA UDI
- GMDN Term
- Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay 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
No
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: Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems PHN Phenytoin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay.
Cleared under the same submission
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 3db6a0cd-c663-4b93-bd80-282c8852bbd2 37 fields · synced May 30, 2026