Duns Number:066761271
Device Description: SysCOR Plus is a System Control convenience kit which contains different levels of control SysCOR Plus is a System Control convenience kit which contains different levels of control material that can be used to correlate results when changing lot numbers of reagents and/or instrument platforms. Similar to the SysCOR kit but with five additional Coumadin® control plasmas.
Catalog Number
-
Brand Name
George King SysCOR Plus Kit
Version/Model Number
0065-35
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
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
7a9a67b5-5639-4f7b-8921-229a68b417ba
Public Version Date
March 29, 2018
Public Version Number
2
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 |