AccessGUDID - DEVICE: Elecsys Free PSA CalCheck (04015630997053)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys Free PSA CalCheck
Version or Model: 03500373190
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03500373190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630997053
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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:	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?
38182	Free (unbound) prostate specific antigen (fPSA) 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 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTG	TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000027	000
P000027	001
P000027	005
P000027	006
P000027	012
P000027	027

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55a93921-58e7-433a-bf9b-03aa0ce890b4
Public Version Date: May 03, 2023
Public Version Number: 8
DI Record Publish Date: December 18, 2014