Duns Number:022156957
Device Description: QBC Malaria Test System - ParaLens Advance with 60X Objective, Microscope, and Capillary C QBC Malaria Test System - ParaLens Advance with 60X Objective, Microscope, and Capillary Centrifuge
Catalog Number
424350
Brand Name
QBC Diagnostics
Version/Model Number
424350
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
K891276
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
d8a062b7-c7ea-4e5f-b033-cd1f90a932ef
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 351 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |