AccessGUDID - DEVICE: Elecsys Testosterone II (07613336170557)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys Testosterone II
Version or Model: 08946353190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08946353190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336170557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: Testosterone G2 Elecsys cobas e 100 V2

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):	Yes
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 [?]
K211685	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: 117f4fa1-9c73-4a96-b56a-3047d63edc28
Public Version Date: May 03, 2023
Public Version Number: 2
DI Record Publish Date: May 21, 2022