Duns Number:276816717
Device Description: VIDAS ® Prolactin (PRL) assay is a quantitative immunoassay intended for use on VIDAS fami VIDAS ® Prolactin (PRL) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of prolactin concentration in human serum or plasma .
Catalog Number
-
Brand Name
VIDAS® Prolactin
Version/Model Number
30410-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 29, 2020
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
-
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
CFT
Product Code Name
RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
Public Device Record Key
2cd58615-5896-409c-8909-b171ed932df6
Public Version Date
October 20, 2021
Public Version Number
2
DI Record Publish Date
November 19, 2019
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |