AccessGUDID - DEVICE: PreciControl Release HBsAg II (07613336182994)

GUDID

Device Identifier (DI) Information

Brand Name: PreciControl Release HBsAg II
Version or Model: 09366717190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09366717190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336182994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *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?
42000	Hepatitis B virus surface antigen 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 Hepatitis B virus surface antigen in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QHM	Serology tests used for infectious disease screening of blood and plasma donations

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: f133335a-89a8-4bb1-8f7f-bc81c3903a6a
Public Version Date: February 20, 2025
Public Version Number: 2
DI Record Publish Date: November 07, 2024