Duns Number:045623154
Device Description: Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation ex Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.1 x 120 ml
Catalog Number
13-G7540-RES-120
Brand Name
Pointe Scientific, Inc. Glyco Resin
Version/Model Number
13-G7540-RES-120
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
K860572
Product Code
LCP
Product Code Name
Assay, Glycosylated Hemoglobin
Public Device Record Key
1d9a9742-b42b-4b3f-aa14-1473b02ccb77
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 |