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Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests) FDA UDI
- Generic Name
- Legionella pneumophila nucleic acid IVD, reagent FDA UDI
- Device Name
- Direct fluorescent polyvalent antibody kit for the identification of Legionella pneumophila serogroups 1-14. Each kit has enough reagents for 50 tests. FDA UDI
- Model / Reference
- PL.242 FDA UDI
- Description
- Direct fluorescent polyvalent antibody kit for the identification of Legionella pneumophila serogroups 1-14. Each kit has enough reagents for 50 tests. FDA UDI
Identifiers
- Catalog Number
- PL.242 FDA UDI
- Primary DI / UDI-DI
- 10628429001841 FDA UDI
- FDA Product Code
- LHL FDA UDI
- GMDN Term
- Legionella pneumophila nucleic acid IVD, reagent 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: Legionella pneumophila nucleic acid IVD, reagent
Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests) by Pro-Lab, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Legionella pneumophila nucleic acid IVD, reagent.
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- Prolex Legionella pneumophila Serogroup 14 Latex 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 5f3ed271-a0ef-467f-8c47-dbaf30afa09e 34 fields · synced May 30, 2026