LIAISON MeMed BV

Primary DI
08056771602969
Brand
LIAISON MeMed BV
Company
Diasorin Inc.
Model
318470
Device description
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.
Published
2022-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QPSImmunoassay For Host Biomarkers Of Infection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPSImmunoassay For Host Biomarkers Of InfectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213936000LIAISON MeMed BV, LIAISON MeMed BV Control SetDiaSorin, Inc.2022-07-14QPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771602969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771602969080567716029698056771602969

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. It is typically used to differentiate bacterial from viral infection, and/or to predict patient outcomes by grading disease severity. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033429783
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056771104418LIAISON QuantiFERON TB Gold Plus II3110852026-02-20
18056771104415LIAISON QuantiFERON TB Gold Plus II3110852026-02-20
08056771104470LIAISON Control QuantiFERON TB Gold Plus II3110812026-02-20
08056771104401LIAISON QuantiFERON TB Gold Plus II3110802026-02-19
08056771600811ANAFLUOR™16622016-09-24
08056771600828ANAFLUOR™16602016-09-24
08056771600835ANAFLUOR ™16242016-09-24
08056771600842ANAFLUOR™66242016-09-24
08056771600859ANAFAST™ ANA Fluorescent Test System 240 Wells16702016-09-24
08056771600897CT-3 Immunoscreen Fluoro-Kit™17402016-09-24
08056771600903CT-2 Immunoscreen Fluoro-Kit™17412016-09-24
08056771600910RS Fluoro-Kit™19702016-09-24
08056771600927ANAFLUOR™ Combo-Pak18122016-09-24
08056771600934ANA HEp-2 6-well Slide Pack16632016-09-24
08056771600941ANA HEp-2 12-well Slide Pack16612016-09-24
08056771600965CT-3 6-well Slide Pack18012016-09-24
08056771600972CT-2 Slide Pack16312016-09-24
08056771601030Fluorescent Antibody (HEp-2) Conjugate16642016-09-24
08056771600118LIAISON® Control HSV-2 IgG3106212016-09-24
08056771602778LIAISON 25 OH Vitamin D Total Assay 200 test3183602021-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290018739089MeMed BV® CalibratorMEMED DIAGNOSTICS LTDQPS2023-07-17
17290018739010MeMed BV®MEMED DIAGNOSTICS LTDQPS2021-12-06
17290018739003MeMed Key®MEMED DIAGNOSTICS LTDQPS2021-10-26
17290018739027MeMed BV® CalibratorMEMED DIAGNOSTICS LTDQPS2021-10-26
17290018739034MeMed BV® External ControlMEMED DIAGNOSTICS LTDQPS2021-10-26