AccessGUDID - DEVICE: cobas® HBV/HCV/HIV-1 Control Kit (00875197006476)

GUDID

Device Identifier (DI) Information

Brand Name: cobas® HBV/HCV/HIV-1 Control Kit
Version or Model: 09040773190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09040773190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197006476
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:	No
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?
48218	HIV1/Hepatitis C virus/Hepatitis B 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 human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid and/or Hepatitis B virus nucleic acid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZF	Test, HIV detection

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: 3f40e9ba-4277-462e-9189-233d2a30ecdd
Public Version Date: December 22, 2021
Public Version Number: 1
DI Record Publish Date: December 10, 2021