Duns Number:072915986
Device Description: Spinal and body fluid control for evaluating the accuracy and precision of hematology inst Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 2.
Catalog Number
200068
Brand Name
Cell-Chex Auto
Version/Model Number
200068
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
K053362
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
5d65e590-332b-46ee-aa93-f1aeaa14e209
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 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 |