Identity
- Trade Name
- Legionella pneumophila Serogroup 7 DFA Reagent FDA UDI
- Generic Name
- Legionella pneumophila nucleic acid IVD, reagent FDA UDI
- Device Name
- The Direct Fluorescent Antibody Reagents are intended for the presumptive (serological) identification of Legionella pneumophila serogroups 2 through 14 from culture isolates. FDA UDI
- Model / Reference
- PL.276 FDA UDI
- Description
- The Direct Fluorescent Antibody Reagents are intended for the presumptive (serological) identification of Legionella pneumophila serogroups 2 through 14 from culture isolates. FDA UDI
Identifiers
- Catalog Number
- PL.276 FDA UDI
- Primary DI / UDI-DI
- 10628429001858 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 Serogroup 7 DFA Reagent by Pro-Lab, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 1f6af191-9f4f-4911-964e-82e4ec5c0e59 34 fields · synced Jun 6, 2026