DiaSorin, Inc

FDA Filings

This page includes the latest FDA filings for DiaSorin, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
DiaSorin Inc.
LIAISON XL Zika Capture IgM II And LIAISON XL Zika Capture IgM II Control Set2019-10-28
DiaSorin Inc.
LIAISON Vitamin B122019-10-02
DiaSorin Inc.
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device2018-12-26
DiaSorin Molecular LLC
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack2018-12-19
DiaSorin Molecular LLC
Simplexa GBS Direct, Simplexa GBS Positive Control Pack2018-11-07
DiaSorin Inc.
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set2018-08-31
DiaSorin Molecular LLC
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack2018-08-13
DiaSorin Molecular LLC
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack2018-03-14
DiaSorin Inc.
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers2018-02-27

Latest Premarket Applications

PMAManufacturerDevice NameDate
DiaSorin, Inc.
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software2019-11-26
DIASORIN, INC.
ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test2019-09-27
DIASORIN, INC.
ETI-CORE-IGMK PLUS assay2019-09-27
DIASORIN, INC.
ETI-AB-COREK PLUS assay2019-09-27
DIASORIN, INC.
ETI-EBK PLUS Aassay2019-09-27
DIASORIN, INC.
ETI-AB-AUK PLUS assay2019-09-27
DIASORIN, INC.
ETI-AB-EBK PLUS assay2019-09-27
DIASORIN, INC.
ETI-CORE-IGMK Plus Assay2019-07-18
DIASORIN, INC.
ETI-AB-COREK Plus Assay2019-07-18
DIASORIN, INC.
ETI-MAK-2 Plus Assay2019-07-18
DIASORIN, INC.
ETI-AB-AUK Plus Assay2019-07-18
DIASORIN, INC.
ETI-AB-EBK Plus Assay2019-07-18
DIASORIN, INC.
ETI-EBK Plus Assay2019-07-18
DIASORIN
Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS)2019-06-13
DIASORIN
Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS)2019-06-13
DIASORIN
Parvovirus B19 IgM Immunoassy (V619IMUS)2019-04-17
DIASORIN, INC.
ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays2018-06-28
DIASORIN, INC.
ETI-AB-EBK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-AB-AUK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-EBK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-CORE-IGMK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-AB-COREK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays2018-04-24
DIASORIN, INC.
ETI-AB-EBK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-AB-AUK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-EBK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-CORE-IGMK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-AB-COREK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-AB-COREK PLUS Assay2018-03-14
DIASORIN, INC.
ETI-CORE-IGMK PLUS Assay2018-03-14

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Simplexa™ VZV Positive Control Pack
DIASORIN MOLECULAR LLC2019-06-27
Simplexa™ VZV Direct
DIASORIN MOLECULAR LLC2019-06-27
LIAISON Elastase-1 Control Set
Diasorin Inc.2019-06-03
LIAISON Elastase-1
Diasorin Inc.2019-06-03
Simplexa™ GBS Positive Control Pack
DIASORIN MOLECULAR LLC2018-12-21
Simplexa™ GBS Direct
DIASORIN MOLECULAR LLC2018-12-21
Simplexa™ Bordetella Positive Control Pack
DIASORIN MOLECULAR LLC2018-09-24
Simplexa™ Bordetella Direct
DIASORIN MOLECULAR LLC2018-09-24
Direct Amplification Disc
DIASORIN MOLECULAR LLC2018-07-06
Universal Disc
DIASORIN MOLECULAR LLC2018-07-06
Direct Amplification Disc Kit
DIASORIN MOLECULAR LLC2018-07-06
Direct Amplification Disc
DIASORIN MOLECULAR LLC2018-07-06
Universal Disc
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ C.difficile Sample Prep Kit
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ C. difficile Positive Control Pack
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ C. difficile Direct
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ C. difficile Universal Direct
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ Group A Strep Positive Control Pack
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ Group A Strep Direct
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ Influenza A H1N1 (2009)
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ HSV 1 & 2 Positive Control Pack
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ HSV 1 & 2 Direct
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ Spectral Calibration Panel
DIASORIN MOLECULAR LLC2018-07-06
STRATIFY JCV™ DXSELECT™
DIASORIN MOLECULAR LLC2018-07-06
STRATIFY JCV™ DXSELECT™
DIASORIN MOLECULAR LLC2018-07-06
HerpeSelect® 2 ELISA IgG
DIASORIN MOLECULAR LLC2018-07-06
HerpeSelect® 2 ELISA IgG
DIASORIN MOLECULAR LLC2018-07-06
HerpeSelect® 1 ELISA IgG
DIASORIN MOLECULAR LLC2018-07-06
HerpeSelect® 1 ELISA IgG
DIASORIN MOLECULAR LLC2018-07-06
West Nile Virus IgM Capture DxSelect™
DIASORIN MOLECULAR LLC2018-07-06
West Nile Virus IgM Capture DxSelect™
DIASORIN MOLECULAR LLC2018-07-06
West Nile Virus IgG DxSelect™
DIASORIN MOLECULAR LLC2018-07-06
West Nile Virus IgG DxSelect™
DIASORIN MOLECULAR LLC2018-07-06
HerpeSelect® 1 and 2 Immunoblot IgG
DIASORIN MOLECULAR LLC2018-07-06
Simplexa™ Flu A/B & RSV Positive Control Pack
DIASORIN MOLECULAR LLC2018-03-29

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