FDA.reportPublic FDA data

LIAISON MeMed BV Control Set

Primary DI
08056771602976
Brand
LIAISON MeMed BV Control Set
Company
Diasorin Inc.
Model
318471
Device description
The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay.
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
QCHAssayed Quality Control Material For Clinical Microbiology Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCHAssayed Quality Control Material For Clinical Microbiology AssaysMicrobiology2

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
08056771602976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771602976080567716029768056771602976

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cell-mediated host immune response marker IVD, controlA material which is used to verify the performance of an assay 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. It is typically used to aid in the differentiation of bacterial and viral infection, and/or to predict patient outcomes by grading disease severity.

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
05391523442121Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442251Multichem ID-HIV p24 Mini KitTECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442435Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
15099590806453Access anti-HAV IgM CalibratorBeckman Coulter, Inc.QCH2026-04-23
00380740197643AlinityAbbott GmbHQCH2023-11-04
00380740174347AlinityAbbott GmbHQCH2022-11-26
00630414607054DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414298405DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414247014ADVIA Centaur Zika IgM QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414247038ADVIA Centaur Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286846Atellica IM Zika IgM ControlsSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286860Atellica IM Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
08056771602648LIAISON® XL Zika Capture IgM II Control SetDiasorin Inc.QCH2019-12-04
07613336129746PreciControl Anti-HAV IIRoche Diagnostics GmbHQCH2019-09-30
00630414587448ADVIA Centaur CMV IgG QCSiemens Healthcare Diagnostics Inc.QCH2019-02-10
00630414246482Atellica IM CMV IgG Quality ControlSiemens Healthcare Diagnostics Inc.QCH2018-11-30