Identity
- Trade Name
- cobas x 480 Analyzer FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Model / Reference
- 05200890001 FDA UDI
Identifiers
- Catalog Number
- 05200890001 FDA UDI
- Primary DI / UDI-DI
- 04015630929009 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
The cobas x 480 Analyzer is a laboratory device designed for the precise measurement of clinical sample concentrations. It features an electrically-powered generator, reservoir, and nebulizing chamber, making it suitable for use in home and clinical settings.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI 91b9e55a-9035-4b26-9753-4b34b75f3757 34 fields · synced Jul 17, 2026