Duns Number:045623154
Device Description: Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic u Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 500 ml
Catalog Number
13-G7521-500
Brand Name
Pointe Scientific, Inc. Glucose Ox
Version/Model Number
13-G7521-500
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
K970781
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
e95e4474-3b83-4bbd-aff3-9d6f3250bf43
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |