Duns Number:072915986
Device Description: A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assess A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter.
Catalog Number
285536
Brand Name
A1c-Cellular Linearity
Version/Model Number
285536
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040025
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
8ad0f517-b14b-4941-ab9b-a5f0dc6c53f5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |