AccessGUDID - DEVICE: ADVIA Centaur® H2n (00630414471235)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® H2n
Version or Model: 10308994
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 915031
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414471235
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HER-2/neu - CENTAUR - RGT - 50 tests

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?
60980	Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, in a clinical specimen using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NCW	SYSTEM, TEST, HER-2/NEU, MONITORING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024017	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: ed16d0f1-734f-4085-874c-e9b1cebd617a
Public Version Date: February 06, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2016