Duns Number:072915986
Device Description: A 5-part differential control that monitors all parameters, including reticulocytes and nu A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials each of low, normal & high levels.
Catalog Number
225485
Brand Name
STaK-Chex Plus Retics
Version/Model Number
225485
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
K090137
Product Code
GLQ
Product Code Name
Mixture, Control, White-Cell And Red-Cell Indices
Public Device Record Key
a07116ce-6736-49a8-a654-dc92fc0cfc39
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |