Duns Number:132528295
Device Description: VARIANT nbs Sickle Cell Program Retention Time Marker Set
Catalog Number
2503004
Brand Name
VARIANT nbs
Version/Model Number
250-3004
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)
Yes
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
K051072
Product Code
GKA
Product Code Name
ABNORMAL HEMOGLOBIN QUANTITATION
Public Device Record Key
da8fe47c-b079-48fe-8ab7-faffdc92e87a
Public Version Date
July 29, 2021
Public Version Number
6
DI Record Publish Date
September 12, 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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |