Identity
- Trade Name
- Atellica CH Reaction Ring Segment FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, reusable FDA UDI
- Device Name
- Atellica CH Reaction Ring Segment FDA UDI
- Model / Reference
- 11099326 FDA UDI
- Description
- Atellica CH Reaction Ring Segment FDA UDI
Identifiers
- Catalog Number
- 11099326 FDA UDI
- Primary DI / UDI-DI
- 00630414596143 FDA UDI
- 510(k) Number
- K161954 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Laboratory analyser cuvette IVD, reusable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory analyser cuvette IVD, reusable
Atellica CH Reaction Ring Segment by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory analyser cuvette IVD, reusable.
Cleared under the same submission
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI cf8709e8-eb8b-4e03-b490-46dce7da7e26 37 fields · synced May 30, 2026