AccessGUDID - DEVICE: cobas liat SARS-CoV-2 v2 nucleic acid test (00875197006292)

GUDID

Device Identifier (DI) Information

Brand Name: cobas liat SARS-CoV-2 v2 nucleic acid test
Version or Model: 09049339190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09049339190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197006292
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:	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?
64747	SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QWR	Simple point-of-care device to detect SAR-CoV-2 nucleic acid targets from clinical specimens in near-patient settings

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243346	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: e13aa8e1-bf87-4131-b500-5f76e1fe8883
Public Version Date: June 05, 2025
Public Version Number: 1
DI Record Publish Date: May 28, 2025