Duns Number:048144997
Device Description: For the in vitro quantitative measurement of glucose in serum. The measurement of glucose For the in vitro quantitative measurement of glucose in serum. The measurement of glucose concentrations in biological fluids has been well documented. Glucose testing can be diagnostically significant in diabetes, hypoglycemia, and various adrenal and pituitary disorders.
Catalog Number
501-411
Brand Name
Glucose Reagent
Version/Model Number
500mL
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CFR
Product Code Name
Hexokinase, Glucose
Public Device Record Key
1aa251a0-6f99-44e6-a954-2847d4f9fb12
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 12, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |