Identity
- Trade Name
- cobas® CMV Control Kit FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 09040919190 FDA UDI
Identifiers
- Catalog Number
- 09040919190 FDA UDI
- Primary DI / UDI-DI
- 00875197006490 FDA UDI
- FDA Product Code
- PAB FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3180 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
cobas® CMV Control Kit by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT).
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- RealTime — Abbott Molecular · Class II
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- Aptima® — Hologic, Inc. · Class II
- MGB Alert® CMV 3.0 Probe Mix ASR - 48 Reaction — ELITechGroup MDX LLC. · Class I
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- artus® CMV QS-RGQ MDx Kit — Qiagen, Inc. · Class II
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
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI 6fb759b9-4074-4b58-8df1-a1a4b3d73290 33 fields · synced Jun 9, 2026