AccessGUDID - DEVICE: VIDAS® (03573026156985)

GUDID

Device Identifier (DI) Information

Brand Name: VIDAS®
Version or Model: TPSA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 30428-01
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026156985
Issuing Agency: GS1
Commercial Distribution End Date: March 23, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate specific antigen (PSA) in human serum, using an enzyme immunoassay (EIA) method.

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:	No
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?
54664	Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)	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 an enzyme immunoassay (EIA) 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 [?]
P040008	000
P040008	001
P040008	002
P040008	003
P040008	004
P040008	005
P040008	006
P040008	007
P040008	008
P040008	011
P040008	012

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: 4bc87b37-a9db-4eed-a982-b7a49be1f361
Public Version Date: February 06, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2014