Duns Number:005088112
Device Description: Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Catalog Number
K6451
Brand Name
Dimension Vista® System TPSA Flex® Reagent Cartridge
Version/Model Number
10445090
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P000021,P000021,P000021,P000021,P000021,P000021,P000021,P000021
Product Code
MTF
Product Code Name
Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
Public Device Record Key
9e403e58-69cb-4115-a86b-fe9561bafbae
Public Version Date
November 18, 2021
Public Version Number
7
DI Record Publish Date
September 24, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |