Duns Number:619834542
Device Description: REAADS Coagulation Control 2 (CC-2) ) is an assayed control plasma in coagulation studies REAADS Coagulation Control 2 (CC-2) ) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use.PRINCIPLE OF THE PROCEDURECoagulation Control 2 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert.
Catalog Number
702-001
Brand Name
REAADS Coagulation Control 2
Version/Model Number
702-001
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
K100103
Product Code
GGC
Product Code Name
Control, Plasma, Abnormal
Public Device Record Key
a24600ff-0699-4375-857c-0707882ccc3e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 14, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |