AccessGUDID - DEVICE: COBAS® AmpliPrep / COBAS® TaqMan® Wash Reagent (00875197002034)

GUDID

Device Identifier (DI) Information

Brand Name: COBAS® AmpliPrep / COBAS® TaqMan® Wash Reagent
Version or Model: 03587797190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03587797190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197002034
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?
58236	Buffered wash solution IVD	A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	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: a652fa42-56f6-4623-bcbb-24c9041fced2
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: September 10, 2014