Duns Number:388240673
Device Description: Quantative determination of protein C activity as an aid in the diagnosis of inherited and Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Catalog Number
OUVV17
Brand Name
Berichrom® Protein C
Version/Model Number
10446500
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K890634
Product Code
GGP
Product Code Name
TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY
Public Device Record Key
31370c09-703e-4dd7-99f1-a5be585be842
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |