AccessGUDID - DEVICE: Elecsys AntiHAV Assay (04015630938841)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys AntiHAV Assay
Version or Model: 5524261160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5524261160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630938841
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:	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?
48272	Hepatitis A virus antigen IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis A virus antigens in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOL	Hepatitis a test (antibody and igm antibody)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100903	000

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: 78ca9fd7-6cfa-403a-a05e-f23be36b40b6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016