Duns Number:388240673
Device Description: The Behring Coagulation System (BCS XP System) performs quantitative assays of specific pa The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Catalog Number
OVOB03
Brand Name
BCS® XP System
Version/Model Number
10459330
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
K970431
Product Code
GKP
Product Code Name
INSTRUMENT, COAGULATION, AUTOMATED
Public Device Record Key
d7987d66-3186-4ba8-a1dc-8354cdb37921
Public Version Date
September 16, 2022
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 |