AccessGUDID - DEVICE: ADVIA Centaur® CARB MCM (00630414527178)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® CARB MCM
Version or Model: 10322042
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5166886
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414527178
Issuing Agency: GS1
Commercial Distribution End Date: March 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Carbamazepine Master Curve Material Set - CENTAUR - CONS

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?
55371	Carbamazepine therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug carbamazepine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLT	ENZYME IMMUNOASSAY, CARBAMAZEPINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964765	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
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: 4e5c661c-9226-4db4-9c27-46fdf87fd889
Public Version Date: July 17, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016