Identity
- Trade Name
- Atellica IM CKMB FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- CKMB Atellica IM - RGT 500T FDA UDI
- Model / Reference
- 10995531 FDA UDI
- Description
- CKMB Atellica IM - RGT 500T FDA UDI
Identifiers
- Catalog Number
- 10995531 FDA UDI
- Primary DI / UDI-DI
- 00630414598581 FDA UDI
- 510(k) Number
- K962126 FDA UDI
- FDA Product Code
- JHS FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Atellica IM CKMB by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class I
- Elecsys CK-MB — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Elecsys CKMB STAT Immunoassay — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- CK-MB AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
Cleared under the same submission
K962126 also covers:
- ADVIA Centaur® CKMB — Siemens Healthcare Diagnostics
- ADVIA Centaur® CKMB Diluent — Siemens Healthcare Diagnostics
- ADVIA Centaur® CKMB MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems CKMB Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CKMB — Siemens Healthcare Diagnostics
- Atellica IM CKMB — Siemens Healthcare Diagnostics
- Atellica IM CKMB Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CKMB DIL — Siemens Healthcare Diagnostics
- Atellica IM CKMB MCM — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI cb37241c-51f1-46fd-9615-f707317bbc3b 37 fields · synced Jun 8, 2026