AccessGUDID - DEVICE: ADVIA Centaur® Active B12 (00630414603117)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Active B12
Version or Model: 10995090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995090
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414603117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Active B12 - CENTAUR - MCM

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?
62122	Holotranscobalamin (holoTC) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of holotranscobalamin (holoTC), also known as active-B12, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160757	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 66caecc4-3030-4a64-ae25-df2c2036ffc3
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020