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.
VIDAS® - TPSA
Device Description
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.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MTF
Device Name: Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: IM
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 03573026156985
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A