SSP HLA-A low

GUDID 07340035503040

CareDx AB

HLA class I antigen tissue typing IVD, kit, multiplex
Primary Device ID07340035503040
NIH Device Record Key0ac0b390-b97b-4dc5-a400-82dba95fea35
Commercial Distribution StatusIn Commercial Distribution
Brand NameSSP HLA-A low
Version Model Number101.401-12u
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
GS107340035503040 [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

On-Brand Devices [SSP HLA-A low]

07340035503040101.401-12u
07340035503026101.401-48u

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