Duns Number:005088112
Device Description: Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator
Catalog Number
DF105A
Brand Name
Dimension® Flex Reagent Cartridge HB1C
Version/Model Number
10483822
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 29, 2022
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
K102510,K102510
Product Code
JJX
Product Code Name
SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
Public Device Record Key
fbdf08fc-69a4-436f-8e38-bac18ce5124b
Public Version Date
August 30, 2022
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 |