AccessGUDID - DEVICE: total PSA Calset II (07613336154380)

GUDID

Device Identifier (DI) Information

Brand Name: total PSA Calset II
Version or Model: 04485220160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04485220160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336154380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use
Previous DI: 04015630920754

Device Description: Total PSA G2 CS Elecsys V2.1

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?
38208	Total prostate specific antigen (tPSA) IVD, calibrator	A material which is used to establish known points of reference for 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
MTF	Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990056	024

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: 8998114c-1109-40cc-b081-77d473ec2d3b
Public Version Date: November 10, 2021
Public Version Number: 5
DI Record Publish Date: September 29, 2017