Duns Number:276816717
Device Description: VIDAS ® Progesterone (PRG) assay is a quantitative IA intended for use on VIDAS family ins
Catalog Number
-
Brand Name
VIDAS® Progesterone
Version/Model Number
30409-01
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
-
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
K965084
Product Code
JLS
Product Code Name
RADIOIMMUNOASSAY, PROGESTERONE
Public Device Record Key
cb02f718-a496-4d65-8b09-c0187bce5513
Public Version Date
August 05, 2019
Public Version Number
1
DI Record Publish Date
July 26, 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 |