FDA.reportPublic FDA data

LIAISON® XL Zika Capture IgM II

Primary DI
08056771602624
Brand
LIAISON® XL Zika Capture IgM II
Company
Diasorin Inc.
Model
317150
Published
2019-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFOZika Virus Serological Reagents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFOZika Virus Serological ReagentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192046000LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetDiaSorin, Inc.2019-10-28QFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771602624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771602624080567716026248056771602624

GMDN Terms#

Term, Definition table
TermDefinition
Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-439-9710info@diasorin.com

Regulatory Flags#

DUNS number
033429783
Device count
1
Kit
true
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
00607158000106DPP Zika IgM SystemChembio Diagnostic Systems Inc.QFO2020-08-06
00630414247007ADVIA Centaur Zika IgM 50TSiemens Healthcare Diagnostics Inc.QFO2020-02-24
00630414247021ADVIA Centaur Zika Ab 100TSiemens Healthcare Diagnostics Inc.QFO2020-02-24
00630414286839Atellica IM Zika IgM 50TSiemens Healthcare Diagnostics Inc.QFO2020-02-24
00630414286853Atellica IM Zika Ab 100TSiemens Healthcare Diagnostics Inc.QFO2020-02-24
B379ZKM21ZIKV Detect™ 2.0 IgM Capture ELISAINBIOS INTERNATIONAL, INCQFO2019-05-24