AccessGUDID - DEVICE: Atellica™ IM HBeAg QC (00630414599229)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica™ IM HBeAg QC
Version or Model: 10995599
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995599
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414599229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL

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):	No
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?
38656	Hepatitis B virus e-antigen immunoglobulin G (IgG) 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 Hepatitis B virus e-antigen immunoglobulin G (IgG) 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 [?]
P090024	001
P090024	002
P090024	003
P090024	004
P090024	005

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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
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: af0c53b2-201c-47f3-8dc4-ace5ca5c6004
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: October 16, 2018