Identity
- Trade Name
- Ferritin ELISA FDA UDI
- Generic Name
- Ferritin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- This Ferritin ELISA is intended for use in the quantitative determination of ferritin in human serum. The assay is to be used in the diagnosis of diseases affecting iron metabolism. FDA UDI
- Model / Reference
- 25-FERHU-E01 FDA UDI
- Description
- This Ferritin ELISA is intended for use in the quantitative determination of ferritin in human serum. The assay is to be used in the diagnosis of diseases affecting iron metabolism. FDA UDI
Identifiers
- Catalog Number
- 25-FERHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24225FERHUE010 FDA UDI
- FDA Product Code
- DBF FDA UDI
- GMDN Term
- Ferritin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5340 FDA UDI
- Commercial Distribution
- Not 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
Ferritin ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- American Laboratory Products Company
Sources (1)
- FDA UDI 225f61f3-17ca-4fce-9414-a6d202b484bb 37 fields · synced Jun 6, 2026