Duns Number:196929947
Device Description: The Chemcard™ Glucose Test is intended for use as arapid, in vitro method for early identi The Chemcard™ Glucose Test is intended for use as arapid, in vitro method for early identification of abnormal fastingplasma glucose concentration which can be a sign of diabetesor other medical problems. The Chemcard™ Glucose Test providesa preliminary, semi-quantitative result using fingerstick bloodas the test specimen.510K Cleared - CliaWaived
Catalog Number
-
Brand Name
Chemcard Glucose
Version/Model Number
47000
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K943503,K943503,K943503
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
1e9f85e4-81dd-4dbb-9781-1df1d861f9ac
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2016
Package DI Number
00737051736922
Quantity per Package
12
Contains DI Package
00737051736915
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |