AccessGUDID - DEVICE: ADVIA Centaur® TSTO (00630414235271)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® TSTO
Version or Model: 11201912
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11201912
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414235271
Issuing Agency: GS1
Commercial Distribution End Date: August 12, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA Centaur® Testosterone (TSTO) Assay Kit 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?
61077	Total testosterone 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 testosterone in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDZ	RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

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
Special Storage Condition, Specify: Store upright, protect from light, do not freeze, resuspend.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 479fb258-8fd7-4eee-93ef-b6ccd1367498
Public Version Date: May 03, 2023
Public Version Number: 3
DI Record Publish Date: August 12, 2020