AccessGUDID - DEVICE: Anti-HBs CalCheck (07613336159804)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-HBs CalCheck
Version or Model: 04985354160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 04985354160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336159804
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: Anti-HBs CC 3 Elecsys

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:	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?
41998	Hepatitis B virus surface total antibody 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 total antibodies to the Hepatitis B virus surface in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOM	Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010054	038

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: a2d90031-0496-410e-b96a-137bc7b5d687
Public Version Date: February 13, 2024
Public Version Number: 4
DI Record Publish Date: August 30, 2018