AccessGUDID - DEVICE: Atellica IM Androstenedione kit (00630414285566)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM Androstenedione kit
Version or Model: 11200558
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11200558
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414285566
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Androstenedione (Andro) Atellica IM - 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?
54068	Androstenedione IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of androstenedione in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIZ	RADIOIMMUNOASSAY, ANDROSTENEDIONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 8d868f23-24b4-43ee-a797-91dd7d27c5be
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: December 04, 2019