AccessGUDID - DEVICE: BioFire RP2.1/RP2.1plus Control Panel M441 (00852720008114)

GUDID

Device Identifier (DI) Information

Brand Name: BioFire RP2.1/RP2.1plus Control Panel M441
Version or Model: v.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M441
Company Name: Mmqci

Primary DI Number: 00852720008114
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 RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch 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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
47920	Multiple-genus respiratory virus 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 virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	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 [?]
K202196	000

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
Handling Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7802ab3-feca-4072-a65b-b769c80ef3f7
Public Version Date: December 18, 2023
Public Version Number: 2
DI Record Publish Date: September 16, 2021