AccessGUDID - DEVICE: Prolex Legionella micdadei (10628429001810)

GUDID

Device Identifier (DI) Information

Brand Name: Prolex Legionella micdadei
Version or Model: PL.221
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.221
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 10628429001810
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: Each dropper bottle contains 2.7 ml of latex reagent for the detection of Legionella micdadei from culture plates.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62353	Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple species of Legionella bacteria in a clinical specimen, using a fluorescent immunoassay method. Legionella species intended to be detected may include Legionella pneumophila, L. longbeachae, L. jordanis, L. bozemanii, L. gormanii, L. micdadei, and L. dumoffii which are associated with pneumonia-like respiratory infection and Legionnaires' disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d409132a-8c5b-426c-b07f-f66c97e47cfc
Public Version Date: January 02, 2023
Public Version Number: 1
DI Record Publish Date: December 25, 2022