Duns Number:276801933
Device Description: Device that detects and measure hemoglobin variants using capillary electrophoresis
Catalog Number
2007
Brand Name
CAPILLARYS HEMOGLOBIN
Version/Model Number
2007
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
GKA
Product Code Name
Abnormal Hemoglobin Quantitation
Public Device Record Key
3930d8a4-c7fc-411c-b876-99b818e8d9b6
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
January 24, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |