Duns Number:125006353
Device Description: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Tray - 25 Cartri For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Tray - 25 Cartridges has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 25 test cartridges.
Catalog Number
111096
Brand Name
Advanced Instruments GloCyte® Test Cartridge & Tray - 25 Cartridges
Version/Model Number
111096
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
Yes
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
-
Product Code
GKL
Product Code Name
Counter, Cell, Automated (Particle Counter)
Public Device Record Key
acafa369-2111-4249-8fdf-a8bfed4fbed8
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
September 23, 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 | 50 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |