Identity
- Trade Name
- PATHFAST Myo-II FDA UDI
- Generic Name
- Myoglobin IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987595301230 FDA UDI
- 510(k) Number
- K081360 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
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, kit, chemiluminescent immunoassay
PATHFAST Myo-II by Phc Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoglobin IVD, kit, chemiluminescent immunoassay.
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- Alinity — Abbott Ireland Diagnostics · Class II
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- ADVIA Centaur® MYO — Siemens Healthcare Diagnostics · 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
Cleared under the same submission
K081360 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
- Phc Corporation
Sources (1)
- FDA UDI 33a7deb7-0092-477f-b117-edfe9a73f927 34 fields · synced May 30, 2026