Duns Number:022156957
Device Description: QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives, Microscope QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives, Microscope, and Centrifuge (115V)
Catalog Number
427400
Brand Name
QBC Diagnostics
Version/Model Number
427400
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
ed7249bf-01f9-432c-bf59-66883deb736f
Public Version Date
March 11, 2019
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 |