Identity
- Trade Name
- ADVIA Centaur® ACS:180® Calibrator U FDA UDI
- Generic Name
- Myoglobin IVD, calibrator FDA UDI
- Device Name
- Myoglobin - CENTAUR - CAL - 2x2x2mL FDA UDI
- Model / Reference
- 10309996 FDA UDI
- Description
- Myoglobin - CENTAUR - CAL - 2x2x2mL FDA UDI
Identifiers
- Catalog Number
- 111083 FDA UDI
- Primary DI / UDI-DI
- 00630414178493 FDA UDI
- 510(k) Number
- K974325 FDA UDI
- FDA Product Code
- DDR FDA UDI
- GMDN Term
- Myoglobin IVD, calibrator 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, calibrator
ADVIA Centaur® ACS:180® Calibrator U by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoglobin IVD, calibrator.
- MYO CAL SET — Randox Laboratories, Ltd. · Class II
- CalSet Myoglobin — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- Elecsys Myoglobin CalSet — Roche Diagnostics Corp. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Cfas Myoglobin — Roche Diagnostics Corp. · Class II
- Elecsys Myoglobin STAT CalSet — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K974325 also covers:
- 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 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 1157d937-a073-4295-89c5-00d908f475ab 37 fields · synced Jun 8, 2026