AccessGUDID - DEVICE: VITEK® REVEAL™ (00860007326905)

GUDID

Device Identifier (DI) Information

Brand Name: VITEK® REVEAL™
Version or Model: 900-00001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 00860007326905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

Device Description: The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details for the Reveal Instrument are provided in this manual.

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):	Yes
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?
56737	Antimicrobial susceptibility analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of an antimicrobial susceptibility profile by monitoring the growth rate of a microbiological organism from a clinical specimen and/or culture isolate when exposed to a range ofantimicrobials. Growth detection technology used may include immunoassay, colorimetry, chromatography, photometric and/or carbon dioxide production.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SAN	Automated antimicrobial susceptibility test system for positive blood culture samples

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230675	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8591995-1b67-4147-ad7c-a6c9c9204f19
Public Version Date: October 17, 2024
Public Version Number: 1
DI Record Publish Date: October 09, 2024