AccessGUDID - DEVICE: ADVIA Centaur aHBe2 50T Kit (00630414167923)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur aHBe2 50T Kit
Version or Model: 10720831
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10720831
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414167923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T

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?
48348	Hepatitis B virus e-antigen 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 e-antigen 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 [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: store upright and protect from light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eeedf232-9a04-4d17-88e3-61d44b8edf77
Public Version Date: January 24, 2022
Public Version Number: 1
DI Record Publish Date: January 14, 2022