Identity
- Trade Name
- Myoglobin Enzyme Immunoassay Test Kit FDA UDI
- Generic Name
- Myoglobin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. FDA UDI
- Model / Reference
- 7030 FDA UDI
- Description
- The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08305900070309 FDA UDI
- 510(k) Number
- K022660 FDA UDI
- FDA Product Code
- DRR FDA UDI
- GMDN Term
- Myoglobin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2050 FDA UDI
- Commercial Distribution
- Not 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
Myoglobin Enzyme Immunoassay Test Kit by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K022660 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
- Biomerica, Inc.
Sources (1)
- FDA UDI 09a807ab-03e9-4d8a-ad0e-9ae591db0caa 36 fields · synced May 30, 2026