AccessGUDID - DEVICE: Access Hybritech p2PSA Calibrators (H628B037051)

GUDID

Device Identifier (DI) Information

Brand Name: Access Hybritech p2PSA Calibrators
Version or Model: B03705
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B03705
Company Name: Beckman Coulter, Inc.

Primary DI Number: H628B037051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: The Access Hybritech p2PSA Calibrators are intended to calibrate the Access Hybritech p2PSA assay as an aid in distinguishing prostate cancer from benign prostatic conditions using human serum on the Access Immunoassay Systems.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
54669	Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYA	P2psa

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e184ae99-d7ec-494c-a465-ab3185948563
Public Version Date: May 03, 2023
Public Version Number: 5
DI Record Publish Date: September 16, 2014