AccessGUDID - DEVICE: cobas&#x00AE EBV/BKV Control Kit (00875197006254)

GUDID

Device Identifier (DI) Information

Brand Name: cobas&#x00AE EBV/BKV Control Kit
Version or Model: 08688214190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08688214190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197006254
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?
61351	Multiple immunocompromised host infection-associated virus nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple viruses associated with infection of the immunocompromised host, which may include Epstein-Barr virus (EBV), human cytomegalovirus (CMV) and BK virus (BKV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QLX	Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA

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: a466e4f7-f927-4a03-b941-64748d2b07d9
Public Version Date: September 18, 2020
Public Version Number: 1
DI Record Publish Date: September 10, 2020