Identity
- Trade Name
- COBAS® AmpliPrep Instrument FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD, semi-automated FDA UDI
- Model / Reference
- 03051315001 FDA UDI
Identifiers
- Catalog Number
- 03051315001 FDA UDI
- Primary DI / UDI-DI
- 04015630924615 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid sample preparation instrument IVD, semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 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
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
Category: Nucleic acid sample preparation instrument IVD, semi-automated
COBAS® AmpliPrep Instrument by Roche Molecular Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid sample preparation instrument IVD, semi-automated.
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 2abbe4fa-cbef-4211-a2dd-7ab7df129302 33 fields · synced Jun 9, 2026