AccessGUDID - DEVICE: ADVIA Centaur® BR Pre (00630414196688)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® BR Pre
Version or Model: 10310272
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 116746
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414196688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: BR Pretreatment - CENTAUR - CAL - 2x10mL

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?
54578	Cancer antigen 27-29 (CA27-29) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cancer antigen 27-29 (CA27-29) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOI	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982680	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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
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: 35ee6981-02c9-4445-b28a-2b76edb9a482
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016