Identity
- Trade Name
- Anti-Lactoferrin ELISA FDA UDI
- Generic Name
- Multiple-type respiratory pathogen immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Anti-Lactoferrin ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Lactoferrin in human serum or plasma. FDA UDI
- Model / Reference
- EIA-3602 FDA UDI
- Description
- Anti-Lactoferrin ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Lactoferrin in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3602 FDA UDI
- Primary DI / UDI-DI
- 00840239036025 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Multiple-type respiratory pathogen immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Anti-Lactoferrin 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 84ef371a-b073-4e8f-b1e3-b4c9e3debfe4 37 fields · synced Jun 1, 2026