SSP DR Low

GUDID 07340035500025

CareDx AB

HLA class II antigen tissue typing IVD, kit, multiplex
Primary Device ID07340035500025
NIH Device Record Keyd910d61b-f362-4b06-acc4-5f455aee987d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSSP DR Low
Version Model Number101.101-48u
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
GS107340035500025 [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 DR Low]

07340035500049101.101-12u
07340035500025101.101-48u

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