AccessGUDID - DEVICE: ADVIA Centaur ® IL6 100T Kit (00630414010434)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur ® IL6 100T Kit
Version or Model: 10995080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995080
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414010434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA Centaur ® IL-6 100T Kit

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?
53858	Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of interleukin-6 (IL-6) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QLC	Interleukin 6

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: 4f287340-fbe3-4c82-bad0-23698f5669e1
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: January 22, 2021