LIAISON MeMed BV

GUDID 08056771602969

The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples.

Diasorin Inc.

Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid
Primary Device ID08056771602969
NIH Device Record Keya54ff23f-dcea-48f3-bba4-b75a28be2c52
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIAISON MeMed BV
Version Model Number318470
Company DUNS033429783
Company NameDiasorin Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056771602969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QPSImmunoassay For Host Biomarkers Of Infection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-18
Device Publish Date2022-08-10

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