Duns Number:227530649
Device Description: This product is intended for in vitro diagnostic use, in the quality control of the accura This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Glycated Haemoglobin (HbA1c) on clinical chemistry systems.
Catalog Number
HA10155
Brand Name
Liquid Glycated Haemoglobin (HbA1c) Control set (LIQ HbA1c CONTROL)
Version/Model Number
HA10155
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
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
47ff8508-af4f-4493-852f-e9fb3c740025
Public Version Date
January 30, 2020
Public Version Number
1
DI Record Publish Date
January 22, 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 |