Identity
- Trade Name
- Prolex Legionella micdadei FDA UDI
- Generic Name
- Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Each dropper bottle contains 2.7 ml of latex reagent for the detection of Legionella micdadei from culture plates. FDA UDI
- Model / Reference
- PL.221 FDA UDI
- Description
- Each dropper bottle contains 2.7 ml of latex reagent for the detection of Legionella micdadei from culture plates. FDA UDI
Identifiers
- Catalog Number
- PL.221 FDA UDI
- Primary DI / UDI-DI
- 10628429001810 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
No
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
Prolex Legionella micdadei 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.
- Legionella micdadei DFA Reagent — 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 d409132a-8c5b-426c-b07f-f66c97e47cfc 34 fields · synced Jun 1, 2026