Duns Number:312576506
Device Description: Kit for 24 determinations of HLA-DQB alleles; For In Vitro Diagnostic Use
Catalog Number
826220
Brand Name
DQB SSP Kit
Version/Model Number
826220
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
BK020004
Product Code
MZI
Product Code Name
Test,Qualitative,For Hla,Non-Diagnostic
Public Device Record Key
a130fe6c-aa14-431d-b844-e51fefe484b5
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
July 01, 2015
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| U | Unclassified | 21 |