Duns Number:005088112
Device Description: HbA1c Kit containing Hemoglobin A1c Flex® reagent cartridge, 240 tests, and HbA1c Calibrat HbA1c Kit containing Hemoglobin A1c Flex® reagent cartridge, 240 tests, and HbA1c Calibrator (5 levels)
Catalog Number
K3105A
Brand Name
Dimension Vista® Flex® reagent cartridge HbA1c KIT
Version/Model Number
10470481
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2021
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
-
Product Code
JIT
Product Code Name
CALIBRATOR, SECONDARY
Public Device Record Key
93742d68-1dac-46c3-9a50-038ad836c165
Public Version Date
November 18, 2021
Public Version Number
6
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |