Duns Number:687910463
Device Description: It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.
Catalog Number
FRPS 025
Brand Name
FREND
Version/Model Number
FREND PSA Plus
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
-
Product Code
LTJ
Product Code Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Public Device Record Key
19af3bc8-1f05-4d60-8ebb-c897090453cf
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
May 04, 2018
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |