Duns Number:064608573
Device Description: The Xprecia™ System PT Controls; For use with Xprecia System, supplying assayed controls f The Xprecia™ System PT Controls; For use with Xprecia System, supplying assayed controls for prothrombin time (PT).
Catalog Number
10873633
Brand Name
Xprecia™ System PT Controls
Version/Model Number
10873633
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
K151964
Product Code
GGN
Product Code Name
PLASMA, COAGULATION CONTROL
Public Device Record Key
f2edac0b-bf9b-4352-a939-2617ea88496d
Public Version Date
November 19, 2021
Public Version Number
5
DI Record Publish Date
December 16, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |