Identity
- Trade Name
- Legionella micdadei DFA Reagent FDA UDI
- Generic Name
- Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- L. pneumophila serogroup 2 FDA UDI
- Model / Reference
- PL.210 FDA UDI
- Description
- L. pneumophila serogroup 2 FDA UDI
Identifiers
- Catalog Number
- PL.210 FDA UDI
- Primary DI / UDI-DI
- 10628429001728 FDA UDI
- FDA Product Code
- LHL FDA UDI
- GMDN Term
- Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3300 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Legionella micdadei DFA Reagent by Pro-Lab, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.
- Prolex Legionella micdadei — PRO-LAB, INCORPORATED · Class II
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
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI df5db125-111a-4e2f-89f2-6f4249235ae9 34 fields · synced May 30, 2026