AccessGUDID - DEVICE: Elecsys Anti-HBs Immunoassay (04015630919420)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys Anti-HBs Immunoassay
Version or Model: 11820524160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11820524160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630919420
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2019
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:	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?
48316	Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus surface in a clinical specimen, using 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 [?]
P010054	000
P010054	001
P010054	007
P010054	008
P010054	017
P010054	037

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12b5e3ad-e316-4b7e-89f1-f4f5c145e0d3
Public Version Date: July 01, 2019
Public Version Number: 6
DI Record Publish Date: September 10, 2014