AccessGUDID - DEVICE: Elecsys Total PSA Immunoassay (04015630921515)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys Total PSA Immunoassay
Version or Model: 04641655160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 04641655160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630921515
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2018
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?
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
MTF	TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990056	000
P990056	001
P990056	007
P990056	008
P990056	014

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: d17b8e15-1c12-4751-9fd0-ea6208b02436
Public Version Date: February 06, 2020
Public Version Number: 5
DI Record Publish Date: September 10, 2014