Identity
- Trade Name
- cobas 6000 Core Unit FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Model / Reference
- 07354436001 FDA UDI
Identifiers
- Catalog Number
- 07354436001 FDA UDI
- Primary DI / UDI-DI
- 04015630938551 FDA UDI
- 510(k) Number
- K060373 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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: Chemiluminescent immunoassay analyser IVD
cobas 6000 Core Unit by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Chemiluminescent immunoassay analyser IVD.
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- Alinity — Abbott Laboratories, Inc. · N
- VITROS — Ortho-Clinical Diagnostics · Class I
Cleared under the same submission
K060373 also covers:
- Chloride Electrode — Roche Diagnostics Corp.
- Chloride electrode — Roche Diagnostics Corp.
- ISE Reference Electrolyte — Roche Diagnostics Corp.
- OPI Opiates 3002000 — Roche Diagnostics Corp.
- Potassium Electrode — Roche Diagnostics Corp.
- Potassium electrode — Roche Diagnostics Corp.
- Reference electrode — Roche Diagnostics Corp.
- Sodium electrode — Roche Diagnostics Corp.
- Sodium electrode — Roche Diagnostics Corp.
- Tina-quant Complement C3c Ver.2 — Roche Diagnostics Corp.
- cobas 6000 c501 module — Roche Diagnostics Corp.
- cobas 6000 core unit — Roche Diagnostics Corp.
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 Diagnostics Corp.
Sources (1)
- FDA UDI d2b594cd-b358-439f-9531-fcd63f2664b5 34 fields · synced May 30, 2026