Duns Number:227530649
Device Description: This product is intended for in vitro diagnostic use in the calibration of HbA1c on clinic This product is intended for in vitro diagnostic use in the calibration of HbA1c on clinical chemistry systems.
Catalog Number
HA3444
Brand Name
HbA1C CAL
Version/Model Number
HA3444
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021897
Product Code
LCP
Product Code Name
Assay, Glycosylated Hemoglobin
Public Device Record Key
fdaa3836-04ff-4b66-98ab-b69691f7af50
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |