Duns Number:072915986
Device Description: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in h A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 12 tests.
Catalog Number
217661
Brand Name
SICKLEDEX
Version/Model Number
217661
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"
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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
K023656
Product Code
GHM
Product Code Name
Test, Sickle Cell
Public Device Record Key
780b0b05-acbc-42ec-9c0d-888d1e58bedd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 136 |