AccessGUDID - DEVICE: VITEK® REVEAL™ SENSOR PANEL (00860007326929)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00860007326929
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

Device Description: The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria

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):	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?
63834	Antibacterial susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02dc081c-9e6b-4543-ab84-774e5fdd93a8
Public Version Date: October 17, 2024
Public Version Number: 1
DI Record Publish Date: October 09, 2024