Duns Number:048144997
Device Description: For in vitro diagnostic use as a control to monitor the performance of multi-parameter hem For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean.
Catalog Number
502-066
Brand Name
CDS 3PD Hematology Control
Version/Model Number
Tri-Pack 6x4.5 mL
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)
Yes
FDA Premarket Submission
-
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
9d71fb15-a10b-416f-bb20-06ca58ab3d59
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 02, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |