Duns Number:008171162
Device Description: These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglo These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes commercially available freeze-dried controls and dilutes white blood samples.
Catalog Number
-
Brand Name
DILUENT 80
Version/Model Number
103399
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
K162822
Product Code
PDJ
Product Code Name
Hemoglobin A1c Test System
Public Device Record Key
3ae96077-267c-473c-a06a-661f42d3260a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 08, 2018
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. | 50 |