Duns Number:484563742
Device Description: Control plasma for assays aimed to determine the functional phenotype for activated protei Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506).
Catalog Number
502-22
Brand Name
Pefakit
Version/Model Number
502-22
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
K042760
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
761a053c-789f-41c9-bad0-596fb6ebc453
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 25, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |