Duns Number:959103565
Device Description: 50 Test Non-Ported TPSA Immunoassay Kit
Catalog Number
25000001
Brand Name
FastPack® Total PSA Kit (50)
Version/Model Number
TPSA Immunoassay
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
K003094,K003094
Product Code
LTJ
Product Code Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Public Device Record Key
3978ff6f-d38b-4815-9a8c-2c9cd8abd968
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2016
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |