AccessGUDID - DEVICE: chromID™ MRSA /SAID (03573026552091)

GUDID

Device Identifier (DI) Information

Brand Name: chromID™ MRSA /SAID
Version or Model: chromID™ MRSA /SAID
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026552091
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus.

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?
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151688	000
K162076	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: 06e8cd8d-c755-48ed-9b57-b1fb33121444
Public Version Date: February 06, 2020
Public Version Number: 5
DI Record Publish Date: September 16, 2016