Duns Number:804870996
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 250 tests
Catalog Number
GLD-250
Brand Name
Sickle-Heme
Version/Model Number
GLD-250
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
-
Product Code
GHM
Product Code Name
Test, Sickle Cell
Public Device Record Key
de44a2af-413c-4d72-8bd9-b1e2226b22c0
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 13, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |