HLA-B*45

GUDID 07340035504269

CareDx AB

HLA class I antigen tissue typing IVD, kit, multiplex
Primary Device ID07340035504269
NIH Device Record Key9d75a4d8-5502-4ec5-aade-2e1bcedafaff
Commercial Distribution StatusIn Commercial Distribution
Brand NameHLA-B*45
Version Model Number101.564-06u
Company DUNS558836388
Company NameCareDx AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107340035504269 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-26
Device Publish Date2023-07-18

Devices Manufactured by CareDx AB

07340035500025 - SSP DR Low2023-07-26
07340035500049 - SSP DR Low2023-07-26
07340035500087 - SSP DRB1*012023-07-26
07340035500100 - SSP DRB1*012023-07-26
07340035500124 - SSP DRB1*152023-07-26
07340035500148 - SSP DRB1*152023-07-26
07340035500162 - SSP DRB1*162023-07-26
07340035500186 - SSP DRB1*032023-07-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.