AccessGUDID - DEVICE: FilmArray Pneumonia/Pneumoniaplus Control (00852720008022)

GUDID

Device Identifier (DI) Information

Brand Name: FilmArray Pneumonia/Pneumoniaplus Control
Version or Model: v.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M340
Company Name: Mmqci

Primary DI Number: 00852720008022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 172874245 *Terms of Use

Device Description: External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems.

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:	No
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?
61317	Multiple-type respiratory pathogen nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., viruses and bacteria) associated with respiratory disease and/or multiple genes conferring antimicrobial resistance in microorganisms present in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41f08d39-2bc1-4ca3-8c73-49ab86c8259d
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: June 17, 2019