Identity
- Trade Name
- MYO CAL SET FDA UDI
- Generic Name
- Myoglobin IVD, calibrator FDA UDI
- Device Name
- This product is intended for use in the calibration of Myoglobin immunoturbidimetric assays. FDA UDI
- Model / Reference
- MY2456 FDA UDI
- Description
- This product is intended for use in the calibration of Myoglobin immunoturbidimetric assays. FDA UDI
Identifiers
- Catalog Number
- MY2456 FDA UDI
- Primary DI / UDI-DI
- 05055273204681 FDA UDI
- 510(k) Number
- K010700 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Myo Cal Set by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoglobin IVD, calibrator.
- CalSet Myoglobin — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Dimension Vista® MYO CAL — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- Elecsys Myoglobin CalSet — Roche Diagnostics Corp. · Class II
- Atellica IM Calibrator U — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® ACS:180® Calibrator U — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K010700 also covers:
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 3a8c2297-996e-4771-b9c3-842d20ce754e 37 fields · synced May 31, 2026