Identity
- Trade Name
- cobas® EGFR Mutation Test v2 FDA UDI
- Generic Name
- Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 2.0 FDA UDI
Identifiers
- Catalog Number
- 07248563190 FDA UDI
- Primary DI / UDI-DI
- 00875197005448 FDA UDI
- FDA Product Code
- OWD FDA UDI
- GMDN Term
- Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class III 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
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
cobas® EGFR Mutation Test v2 by Roche Molecular Systems, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT).
- therascreen® EGFR RGQ PCR Kit — Qiagen, Inc. · Class III
- cobas® DNA Sample Preparation Kit — Roche Molecular Systems, Inc. · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI 1e75681f-a708-46c8-8db0-4c374ee2d1e0 33 fields · synced Jun 9, 2026