Duns Number:045623154
Device Description: Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. For the in v Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. For the in vitro quantitative measurement of glucose in serum.
Catalog Number
14-G7517-480
Brand Name
Pointe Glucose Hexokinase for BS480
Version/Model Number
14-G7517-480
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
K961282
Product Code
CFR
Product Code Name
Hexokinase, Glucose
Public Device Record Key
119c5dd0-a268-4535-bbf6-74551e91903c
Public Version Date
June 05, 2020
Public Version Number
1
DI Record Publish Date
May 28, 2020
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |