Identity
- Trade Name
- Atellica IM MYO FDA UDI
- Generic Name
- Myoglobin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Myoglobin (MYO) Atellica IM - RGT 50T FDA UDI
- Model / Reference
- 10995649 FDA UDI
- Description
- Myoglobin (MYO) Atellica IM - RGT 50T FDA UDI
Identifiers
- Catalog Number
- 10995649 FDA UDI
- Primary DI / UDI-DI
- 00630414599670 FDA UDI
- 510(k) Number
- K974325 FDA UDI
- FDA Product Code
- DDR FDA UDI
- GMDN Term
- Myoglobin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5680 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: Myoglobin IVD, kit, chemiluminescent immunoassay
Atellica IM MYO by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoglobin IVD, kit, chemiluminescent immunoassay.
- Tina-quant Myoglobin Gen.2 — Roche Diagnostics Corp. · Class II
- Monobind AccuLite Myoglobin CLIA Kit - 192 Wells — MONOBIND, INC. · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- PATHFAST Myo-II — PHC CORPORATION · Class II
- IMMULITE® 2000 Systems MYO Myoglobin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys Myoglobin Immunoassay — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
Cleared under the same submission
K974325 also covers:
- ADVIA Centaur® ACS:180® Calibrator U — Siemens Healthcare Diagnostics
- ADVIA Centaur® MYO — Siemens Healthcare Diagnostics
- ADVIA Centaur® MYO +U — Siemens Healthcare Diagnostics
- ADVIA Centaur® MYO MCM — Siemens Healthcare Diagnostics
- Atellica IM Calibrator U — Siemens Healthcare Diagnostics
- Atellica IM MYO — Siemens Healthcare Diagnostics
- Atellica IM MYO 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 afa5aed2-e485-4b9f-ae64-545c7579d7f9 37 fields · synced May 30, 2026