Duns Number:066761271
Device Description: The AMR Coagulation Kit is a convenience kit that contains three levels of control materia The AMR Coagulation Kit is a convenience kit that contains three levels of control material that can be used to verify the analytical measurement range of the eight different assays.
Catalog Number
-
Brand Name
George King AMR Coagulation Kit
Version/Model Number
0014-30
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 06, 2018
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
Yes
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
-
Product Code
GGC
Product Code Name
Control, Plasma, Abnormal
Public Device Record Key
7a37368d-d196-4d08-979e-f26466586885
Public Version Date
April 06, 2018
Public Version Number
4
DI Record Publish Date
August 19, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 120 |