AccessGUDID - DEVICE: ADVIA Centaur® PSA (00630414203003)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® PSA
Version or Model: 10310292
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 118156
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414203003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Prostate-specific Antigen (PSA) Assay Kit (1-pack) 100T

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?
54665	Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950021	001
P950021	002
P950021	003
P950021	004
P950021	005
P950021	006
P950021	007
P950021	008
P950021	009
P950021	011
P950021	013
P950021	018

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
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: 1022259f-e7c3-4e17-822e-da0c2d1e4c5f
Public Version Date: November 18, 2021
Public Version Number: 7
DI Record Publish Date: September 24, 2014