AccessGUDID - DEVICE: SPOTFIRE RSP Pos & Neg Controls (00852720008145)

GUDID

Device Identifier (DI) Information

Brand Name: SPOTFIRE RSP Pos & Neg Controls
Version or Model: v.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M425
Company Name: Mmqci

Primary DI Number: 00852720008145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 172874245 *Terms of Use

Device Description: POS and NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel and BIOFIRE SPOTFIRE R/ST Panel Mini

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 [?]
K241289	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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe7dd84f-eb99-4d8f-9585-5ea7917e7c4a
Public Version Date: June 26, 2025
Public Version Number: 1
DI Record Publish Date: June 18, 2025