AccessGUDID - DEVICE: Atellica™ IM aHBcM QC (00630414597805)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica™ IM aHBcM QC
Version or Model: 10995450
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995450
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414597805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HBc IgM (aHBcM) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL

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?
41982	Hepatitis B virus core immunoglobulin M (IgM) 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 immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen 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 [?]
P030040	000
P030040	002
P030040	004
P030040	005
P030040	006
P030040	008
P030040	009
P030040	010
P030040	011
P030040	012
P030040	013
P030040	014

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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c82cfa0d-0efa-4ae7-8e73-9d474dc840d5
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: October 16, 2018