Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- Carbamazepine therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- VITROS Chemistry Products CRBM Slides FDA UDI
- Model / Reference
- 8892382 FDA UDI
- Description
- VITROS Chemistry Products CRBM Slides FDA UDI
Identifiers
- Catalog Number
- 8892382 FDA UDI
- Primary DI / UDI-DI
- 10758750005185 FDA UDI
- FDA Product Code
- KLT FDA UDI
- GMDN Term
- Carbamazepine therapeutic drug monitoring IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3645 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Carbamazepine therapeutic drug monitoring IVD, reagent
Vitros by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 48c41a63-eb65-461e-9520-b9a96e151f28 35 fields · synced May 31, 2026