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Prolex Legionella pneumophila Serogroup 1 Latex Reagent (Monoclonal)

FDA UDI

Class II (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
Prolex Legionella pneumophila Serogroup 1 Latex Reagent (Monoclonal) FDA UDI
Generic Name
Legionella pneumophila nucleic acid IVD, reagent FDA UDI
Device Name
This Latex Reagent is intended for the presumptive identification of Legionella pneumophila serogroup 1 from culture plates. FDA UDI
Model / Reference
PL.380 FDA UDI
Description
This Latex Reagent is intended for the presumptive identification of Legionella pneumophila serogroup 1 from culture plates. FDA UDI

Identifiers

Catalog Number
PL.380 FDA UDI
Primary DI / UDI-DI
10628429002107 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

Prolex Legionella pneumophila Serogroup 1 Latex Reagent (Monoclonal) by Pro-Lab, Incorporated — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Legionella pneumophila nucleic acid IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (1)

  • FDA UDI 2642bdd1-45df-4029-9878-cce2c749aac9 34 fields · synced Jun 6, 2026