Duns Number:227530649
Device Description: The HbA1c II Calibrator is intended for use in the calibration of the HbA1c II assay.
Catalog Number
HA8124
Brand Name
HbA1c II CALIBRATOR SET (HbA1c II CAL)
Version/Model Number
HA8124
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
-
Product Code
JIT
Product Code Name
Calibrator, Secondary
Public Device Record Key
3649352d-8c59-4e4f-ba70-a939a7414ab6
Public Version Date
April 24, 2020
Public Version Number
1
DI Record Publish Date
April 16, 2020
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 |