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 Anti-HAV Assay2020-03-02
DiaSorin Molecular LLC
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack2019-11-26
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 Molecular LLC
Simplexa VZV Direct, Simplexa VZV Positive Control Pack2019-05-13
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
DiaSorin Inc.
LIAISON® CMV IgG And LIAISON® CMV IgG Serum Control Set2017-01-06
DIASORIN INC.
LIAISON® VCA IgG And LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG And LIAISON® EBNA IgG Serum Control Set2017-01-05
DIASORIN INC.
LIAISON® EA IgG And LIAISON® EA IgG Serum Control Set2017-01-04
DiaSorin Inc.
LIAISON HAV IgM, LIAISON Control HAV IgM2016-08-25
DIASORIN, INC.
LIAISON H. Pylori IgG, LIAISON H. Pylori IgG Control Set2016-07-22
DiaSorin Inc.
LIAISON CMV IgM Serum Control Set2016-06-30
DiaSorin Inc.
LIAISON EBV IgM Serum Control Set2016-06-30
DiaSorin Inc.
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers2015-06-22
DiaSorin Inc.
LIAISON VZV IgG, LIAISON Control VZV IgG2015-03-11
DiaSorin Inc.
LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS2014-12-10
DIASORIN, INC.
LIAISON XL ANALYZER2014-07-25
DIASORIN, INC.
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS2013-11-08
DIASORIN, INC.
LIAISON XL HCG2013-09-06
DIASORIN, INC.
LIAISON 25 TOTAL-D2013-09-05
DIASORIN, INC.
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II2013-08-28
DIASORIN, INC.
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II2013-08-09
DIASORIN
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS2013-04-09
DIASORIN, INC.
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 32013-04-05

Latest Premarket Applications

PMAManufacturerDevice NameDate
DiaSorin Inc.
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers2020-02-21
DiaSorin Inc.
LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc2020-01-02
DiaSorin, Inc.
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software2019-11-26
DIASORIN, INC.
ETI-AB-COREK PLUS assay2019-09-27
DIASORIN, INC.
ETI-AB-EBK PLUS assay2019-09-27
DIASORIN, INC.
ETI-CORE-IGMK PLUS assay2019-09-27
DIASORIN, INC.
ETI-EBK PLUS Aassay2019-09-27
DIASORIN, INC.
ETI-AB-AUK PLUS assay2019-09-27
DIASORIN, INC.
ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test2019-09-27
DIASORIN, INC.
ETI-AB-COREK Plus Assay2019-07-18
DIASORIN, INC.
ETI-AB-AUK Plus Assay2019-07-18
DIASORIN, INC.
ETI-CORE-IGMK Plus Assay2019-07-18
DIASORIN, INC.
ETI-MAK-2 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-COREK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-AB-EBK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-CORE-IGMK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-EBK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-AB-AUK PLUS Assay2018-06-28
DIASORIN, INC.
ETI-EBK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-AB-EBK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-CORE-IGMK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays2018-04-24
DIASORIN, INC.
ETI-AB-AUK PLUS Assay2018-04-24
DIASORIN, INC.
ETI-AB-COREK PLUS Assay2018-04-24

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
LIAISON® XL MUREX Control HCV Ab
DIASORIN S.P.A.2020-03-04
LIAISON® XL MUREX HCV Ab
DIASORIN S.P.A.2020-03-04
LIAISON Lyme Total Antibody Plus Control set
Diasorin Inc.2020-02-11
LIAISON Lyme Total Antibody Plus
Diasorin Inc.2020-02-11
LIAISON® N-TACT® PTH Gen II Calibration Verifiers
Diasorin Inc.2019-12-23
LIAISON® N-TACT® PTH Gen II Specimen Diluent
Diasorin Inc.2019-12-23
LIAISON® N-TACT® PTH Gen II Control Set
Diasorin Inc.2019-12-23
LIAISON® N-TACT® PTH Gen II
Diasorin Inc.2019-12-23
Simplexa™ VZV Swab Direct
DIASORIN MOLECULAR LLC2019-12-23
LIAISON® QuantiFERON® Software
DIASORIN SPA2019-12-17
LIAISON® Control QuantiFERON®-TB Gold Plus
DIASORIN SPA2019-12-17
LIAISON Quantiferon TB Gold Plus
DIASORIN SPA2019-12-17
LIAISON® XL Zika Capture IgM II Control Set
Diasorin Inc.2019-12-12
LIAISON® XL Zika Capture IgM II
Diasorin Inc.2019-12-12
LIAISON® Vitamin B12 Control Set
Diasorin Inc.2019-12-12
LIAISON® Vitamin B12
Diasorin Inc.2019-12-12
Biotrin Parvovirus B19 IgM EIA
DIASORIN SPA2019-12-05
Biotrin Parvovirus B19 IgG EIA
DIASORIN SPA2019-12-05
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

Related Finance Registrations
DiaSorin SpA/ADR0001544088
Legal Entity Identifier 549300HLU4O97LASLV64 [DIASORIN INC.]

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