AccessGUDID - DEVICE: Elecsys HBsAg Confirmatory Test (07613336175293)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys HBsAg Confirmatory Test
Version or Model: 09127127190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09127127190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336175293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: HBsAg Confirmatory Test Elecsys cobas e V2

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?
60812	Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative neutralization of Hepatitis B virus surface antigens in a clinical specimen, using Hepatitis B virus antibodies of known specificity and a chemiluminescent immunoassay method.	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 [?]
P160019	012

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: b3c32945-669c-4fa3-b42a-9fd1253f6f5a
Public Version Date: February 03, 2022
Public Version Number: 1
DI Record Publish Date: January 26, 2022