AccessGUDID - DEVICE: Atellica IM AB12 (00630414245720)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM AB12
Version or Model: 10733001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10733001
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414245720
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Active-B12 (AB12) Atellica IM - RGT 100T

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?
62120	Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of holotranscobalamin (holoTC), also known as active-B12, in a clinical specimen, using a chemiluminescent immunoassay. It is used to aid in the diagnosis and treatment of vitamin B12 deficiency.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDD	RADIOASSAY, VITAMIN B12

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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 182f100d-05d0-4dc1-b260-5d58dfd8fbf8
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: October 19, 2018