AccessGUDID - DEVICE: ADVIA Centaur® Systems, ACS 180® Systems PSA MCM (00630414202952)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Systems, ACS 180® Systems PSA MCM
Version or Model: 10310294
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 118197
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414202952
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) Master Curve Material Kit

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?
38207	Total prostate specific antigen (tPSA) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (specified) analyte controls (assayed and unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950021	002
P950021	006
P950021	007
P950021	011

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: Lyophilized-until the expiration date on the vial label or reconstituted -21 days or onboard-8hours
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: 3819d609-ea92-4c0e-a8ab-2c76bc691af7
Public Version Date: June 19, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2014