Duns Number:008254708
Device Description: The Access Hybritech PSA Sample Diluent is intended for use with the Access Hybritech PSA The Access Hybritech PSA Sample Diluent is intended for use with the Access Hybritech PSA assay to dilute patient samples containing total prostate specific antigen (PSA) concentrations greater than the S5 calibrator.
Catalog Number
37206
Brand Name
Access Hybritech PSA Sample Diluent
Version/Model Number
37206
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
MTF
Product Code Name
Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
Public Device Record Key
d190ee77-e2b7-451f-a44b-67d3eaf4d8e5
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
September 16, 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 | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |