Duns Number:276816717
Device Description: VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate 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.
Catalog Number
30428-01
Brand Name
VIDAS®
Version/Model Number
TPSA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 23, 2017
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P040008,P040008,P040008,P040008,P040008,P040008,P040008,P040008,P040008,P040008,P040008
Product Code
MTF
Product Code Name
Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |