AccessGUDID - DEVICE: ADVIA Centaur® Calibrator D (00630414124797)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Calibrator D
Version or Model: 10311569
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 672173000
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414124797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Calibrator D - 2 pack (AFP Cal; CEA Cal)

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:	Yes
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?
38221	Multiple tissue-associated protein/tumour marker IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P930036	001
P930036	003

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: 5857dbfe-d112-4239-884c-b323fa7a7cc6
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2014