AccessGUDID - DEVICE: cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System (00875197005950)

GUDID

Device Identifier (DI) Information

Brand Name: cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System
Version or Model: 08160104190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08160104190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197005950
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?
47277	Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus and/or influenza B virus in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay
OOI	Real Time Nucleic Acid Amplification System
OCC	Respiratory Virus Panel Nucleic Acid Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 5d6078b5-8eb6-4242-8a4f-a7a47cbcd1cf
Public Version Date: November 10, 2021
Public Version Number: 3
DI Record Publish Date: January 28, 2017