Duns Number:125006353
Device Description: For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Control Kit For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Control Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains one 3mL vial of Low Level Control and one 3mL vial of High Level Control.
Catalog Number
111013
Brand Name
Advanced Instruments GloCyte® Controls Kit
Version/Model Number
111013
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
K152776
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
ff51502a-61a8-4406-9c85-93e4f3cf3496
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 |