AccessGUDID - DEVICE: Legionella pneumophila Serogroup 9 DFA Reagent (10628429001872)

GUDID

Device Identifier (DI) Information

Brand Name: Legionella pneumophila Serogroup 9 DFA Reagent
Version or Model: PL.278
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.278
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 10628429001872
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: The Direct Fluorescent Antibody Reagents are intended for the presumptive (serological) identification of Legionella pneumophila serogroups 2 through 14 from culture isolates.

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?
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.	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: 684f5576-ddff-44ff-adac-6404afb62b6f
Public Version Date: January 02, 2023
Public Version Number: 1
DI Record Publish Date: December 25, 2022