Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests)

Basic Information

• Brand Name: Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests)
• Primary DI: 10628429001841
• Version / Model: PL.242
• Catalog Number: PL.242
• Company Name: PRO-LAB, INCORPORATED
• Labeler DUNS: 960418395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-25
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: 5f3ed271-a0ef-467f-8c47-dbaf30afa09e

Device Description

Direct fluorescent polyvalent antibody kit for the identification of Legionella pneumophila serogroups 1-14. Each kit has enough reagents for 50 tests.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	866.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51063	Legionella pneumophila nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10628429001841	GS1