AccessGUDID - DEVICE: ADVIA Centaur® SHBG MCM Set (00630414603414)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® SHBG MCM Set
Version or Model: 10997193
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10997193
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414603414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA Centaur Sex Hormone Binding Globulin Master Curve Material (SHBG MCM) Set - 5x1mL - 5 Levels

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?
42182	Sex hormone binding globulin (SHBG) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of sex hormone binding globulin (SHBG) 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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ff836da-161d-495a-8945-ade67b89c146
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020