Identity
- Trade Name
- Ferritin ELISA FDA UDI
- Generic Name
- Ferritin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism. FDA UDI
- Model / Reference
- EIA-1872 FDA UDI
- Description
- The Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism. FDA UDI
Identifiers
- Catalog Number
- EIA-1872 FDA UDI
- Primary DI / UDI-DI
- 00840239018724 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 11 Milliliter FDA UDITotal Volume — 13 Milliliter FDA UDITotal Volume — 0.5 Milliliter FDA UDI
Ferritin ELISA by DRG International, Inc. — 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
- DRG International, Inc.
Sources (1)
- FDA UDI bed28e5a-9f02-4bfe-b323-60e19981aacf 37 fields · synced May 30, 2026