Duns Number:276801933
Device Description: Device used to detect hemoglobin variants using dry blood spots on capillary electrophores Device used to detect hemoglobin variants using dry blood spots on capillary electrophoresis
Catalog Number
2006
Brand Name
CAPILLARYS NEONAT Hb
Version/Model Number
2006
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
30640654-eb6b-4a78-a6c5-47db79d436a9
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 |