Duns Number:125006353
Device Description: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reagent Kit has For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Red Blood Cell (RBC) Reagent.
Catalog Number
111011
Brand Name
Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit
Version/Model Number
111011
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)
Yes
FDA Premarket Submission
K152776,K152776
Product Code
GKL
Product Code Name
Counter, Cell, Automated (Particle Counter)
Public Device Record Key
6a273521-b0c5-4492-96ca-f30f451f1419
Public Version Date
July 06, 2018
Public Version Number
3
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 |