Duns Number:008254708
Device Description: The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybritech PSA as The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybritech PSA assay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
Catalog Number
37205
Brand Name
Access Hybritech PSA Calibrators
Version/Model Number
37205
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
1efd37cb-5d0d-4080-a20b-65765c2b57b7
Public Version Date
February 06, 2020
Public Version Number
3
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 |