Duns Number:087248183
Device Description: CBC-LINE Kit 6 x 3mL (6 vials each of the various levels)RBC Levels 1-6WBC Levels 1-6PLT CBC-LINE Kit 6 x 3mL (6 vials each of the various levels)RBC Levels 1-6WBC Levels 1-6PLT Levels 1,3,4,7,9,10Low Levels 1-6
Catalog Number
CL029
Brand Name
Research and Diagnostic Systems
Version/Model Number
CL029
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K942822
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
0c47f95e-1a5c-489f-ab91-dd8221708a92
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 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. | 135 |