AccessGUDID - DEVICE: COBAS® TaqMan® HBV Test, For Use With The High Pure System (00875197002003)

GUDID

Device Identifier (DI) Information

Brand Name: COBAS® TaqMan® HBV Test, For Use With The High Pure System
Version or Model: 03577163190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03577163190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197002003
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:	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?
48307	Hepatitis 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 Hepatitis B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT). The nucleic acids detected may include genes encoding the core protein, surface antigen, e-antigen, and/or other genome regions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKT	Hepatitis Viral B DNA 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: 563eb0da-6193-4478-9686-8505f212d8d5
Public Version Date: April 21, 2021
Public Version Number: 3
DI Record Publish Date: September 10, 2014