AccessGUDID - DEVICE: cobas&#x00AE vivoDx MRSA Control Media (00875197005820)

GUDID

Device Identifier (DI) Information

Brand Name: cobas&#x00AE vivoDx MRSA Control Media
Version or Model: 08064768190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08064768190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197005820
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071674100 *Terms of Use

Device Description: No description.

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:	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?
64569	MRSA phenotype detection IVD, kit, bioassay	A collection of reagents and other associated materials intended to be used for the phenotypic detection of methicillin-resistant Staphylococcus aureus (MRSA) in live bacteria present in a clinical specimen and/or culture isolate, using a bioassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIV	Culture-based short-term incubation antimicrobial resistance assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190016	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: 49ac5ffb-e2f7-4b50-94dd-55e6081af52d
Public Version Date: January 23, 2020
Public Version Number: 1
DI Record Publish Date: January 15, 2020