DiaSorin Molecular LLC

FDA Device Registration & Listing · CYPRESS, CA, US · Registration 2023365

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2023365
FEI Number
2023365
Entity Name
DiaSorin Molecular LLC
City/State/Country
CYPRESS, CA, US
Establishment Address
11331 Valley View St, CYPRESS, CA 90630, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DiaSorin Molecular LLC (Owner Number: 9089763)
Owner / Operator Contact Address
11331 Valley View Street, --, Cypress, CA 90630, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

IF0300G Arbovirus IFA IgG Kit EL0100G - Parvovirus B19 DxSelect IgG Kit MOL2200 - Simplexa CMV MOL2250 - Simplexa Congenital CMV Direct MOL2260 - Simplexa Congenital CMV Positive Control Pack MOL2210 - Simplexa CMV Quantitation Standards MOL3660 Simplexa VZV Positive Control Pack MOL3655 Simplexa VZV Swab Direct IF1250M - Chlamydia MIF IgM Kit IF1250A - Chlamydia MIF IgA Kit IF1250G - Chlamydia MIF IgG Kit MULTIPLE PARVOVIRUS EL Bartonella IFA IgM - IF1300M Anaplasma phagocytophilum IFA IgG - IF1450G Anaplasma phagocytophilum IFA IgM - IF1450M Bartonella IFA IgG - IF1300G Hantavirus IgM DxSelect - EL1600M Hantavirus IgG DxSelect - EL1600G LIAISON MDX 3M Integrated Cycler EL0920G HerpeSelect® 2 ELISA IgG Kit EL0300G West Nile Virus DxSelect™ IgG Kit MOL3960 Simplexa C. auris Positive Control Pack MOL3950 Simplexa C. auris Direct MOL5390 Simplexa C. auris Sample Prep Kit MOL4150 Simplexa COVID-19 Direct MOL4160 Simplexa COVID-19 Positive Control Pack MOL4165 Simplexa COVID-19 Positive Control GEN II Pack MOL4260 Simplexa COVID-19 & Flu A/B Positive Control Pack MOL4250 Simplexa COVID-19 & Flu A/B Direct IF0200G Q Fever IFA IgG Simplexa™ GBS Positive Control Pack Simplexa™ GBS Direct MOL2150 Simplexa HSV 1 & 2 Direct MOL2160 Simplexa HSV 1 & 2 Positive Control Pack IB0900G HerpeSelect® 1 & 2 Immunoblot IgG Kit Rickettsia IFA IgG Kit EL0300M West Nile Virus IgM Capture DxSelect MOL2655 Simplexa Flu A/B & RSV Direct Gen II MOL2660 Simplexa Flu A/B & RSV Positive Control Pack NES1001 LIAISON NES Instrument NES4460 LIAISON NES FLU A/B, RSV & COVID-19 Control Swab Kit NES4450 LIAISON NES FLU A/B, RSV & COVID-19 NES1001R LIAISON NES Instrument, Refurbished EL0950 HSV Serum Panel IF1410 Anaplasma phagocytophilum IFA IgG Detectable Control IF1314 Bartonella IFA Polyvalent Detectable Control IF1411 Anaplasma phagocytophilum IFA Non- Detectable Control IF1313 Bartonella IFA Non- Detectable Control IF1412 Anaplasma phagocytophilum IFA IgM Detectable Control IF0910 Babesia microti IFA IgG Detectable Control EL1825 Normal Human Serum EL1824 Anti-Natalizumab Control 2 IF1012 Ehrlichia chaffeensis IFA IgM Detectable Control IF1011 Ehrlichia chaffeensis IFA Non-Detectable Control IF1010 Ehrlichia chaffeensis IFA IgG Detectable Control EL1823 Anti-Natalizumab Control 1 Chlamydia MIF IgA & Chlamydia MIF IgG & Chlamydia MIF IgM EL0910G HerpeSelect® 1 ELISA IgG Kit EL1500G - Dengue Virus IgG DxSelect Kit EL1500M - Dengue Virus IgM Capture DxSelect Kit EL1510 - Dengue NS1 Antigen DxSelect WEST NILE VIRUS ELISA REAGENTS IF0300G Arbovirus IFA IgG Kit; IF0300M Arbovirus IFA IgM Kit; MULTIPLE FLAVIVIRUS MOL2400 Simplexa EBV Arbovirus IFA IgM MOL2975 Simplexa™ C.difficile Universal Direct Simplexa Flu A/B & RSV Direct Simplexa Flu A/B & RSV Positive Control Pack Simplexa™ VZV Positive Control Pack Simplexa™ VZV Direct MOL2750 Simplexa Bordetella Direct MOL2760 Simplexa Bordetella Positive Control Pack MOL8011 Simplexa™ Adenovirus Molecular Control MOL8002 Simplexa™ CMV Molecular Control MOL8033 Simplexa™Group A Strep Molecular Control MOL8006 Simplexa™ Bordetella Molecular Control MOL8009 Simplexa™ BKV Molecular Control MOL8008 Simplexa™ EBV Molecular Control MOL3560 Simplexa GBS Positive Control Pack MOL3550 Simplexa GBS Direct MOL9206 Blastomyces Primer Pair IF0102 R. rickettsii Substrate Slide MOL9034 L. pneumophila Primer Pair MOL9056 MTHFR 1298 Mutant Primer Pair MOL9054 MTHFR 677 Mutant Primer Pair MOL9011 ADENOVIRUS 3' HEXON PRIMER PAIR MOL9051 Factor V Wild Type Primer Pair MOL9025 T. gondi Primer Pair IF1003 Ehrlichia chaffeensis IgG Substrate Slide MOL9031 Parainfluenza 2 Primer Pair MOL9004 HSV-2 Primer Pair MOL9094 Group G Strep Primer Pair MOL9022 HHV-6 Primer Pair IF1316-A Bartonella 10X IgG Sample Diluent IF1201-A Chlamydia MIF Substrate Slide IF1301-A Bartonella IgG Substrate Slide MOL9016 Influenza A Primer Pair MOL9042 Dengue Virus 2 Primer Pair MOL9093 Group C Strep Primer Pair MOL9033 Group A Strep Primer Pair IF0104-A Rickettsia Conorii Substrate Slides MOL9009 BKV Primer Pair IF0904 Babesia microti Substrate Slide MOL9007 B. parapertussis Primer Pair MOL9008 EBV Primer Pair MOL9098 Pneumocystis jirovecii Primer Pair IF1004 Ehrlichia chaffeensis IgM Substrate Slide MOL9006 B. pertussis Primer Pair MOL9304 HSV-2 Primer Pair MOL9047 Group B Strep Primer Pair MOL9032 Parainfluenza 3 Primer Pair MOL9044 Dengue Virus 4 Primer Pair EL1822 Biotinylated Natalizumab MOL9017 Influenza B Primer Pair MOL9337 HSV-1 Gen II Primer Pair MOL9019 Parvovirus Primer Pair MOL9039 Chikungunya Primer Pair MOL9035 KPC Primer Pair MOL9023 C. pneumoniae Primer Pair MOL9043 Dengue Virus 3 Primer Pair MOL9013 M. pneumoniae Primer Pair MOL9028 Norovirus II Primer Pair MOL9052 Prothrombin (FII) Mutant Primer Pair IF1403-A Anaplasma phagocytophilum IgG Substrate Slide MOL9011 Adenovirus 3' Hexon Primer Pair MOL9307 B. parapertussis Primer Pair MOL9027 Norovirus I Primer Pair MOL9003 HSV-1 Primer Pair MOL9324 VZV Primer Pair EL0325 COS-1 Antigen (Lyophilized) MOL9020 Enterovirus Primer Pair MOL9038 Parechovirus Primer Pair IF1404-A Anaplasma phagocytophilum IgM Substrate Slide MOL9015 Borrelia Primer Pair MOL9037 HSV-1 Gen II Primer Pair MOL9012 Adenovirus 5' Hexon Primer Pair MOL9021 JCV Primer Pair MOL9333-5 Group A Strep Primer Pair MOL9055 MTHFR 677 Wild Type Primer Pair MOL9057 MTHFR 1298 Wild Type Primer Pair MOL9306 B. pertussis Primer Pair MOL9053 Prothrombin (FII) Wild Type Primer Pair EL1821 Natalizumab MOL9014 RSV Primer Pair MOL9024 VZV Primer Pair MOL9058 M. pneumoniae II Primer Pair IF1302-A Bartonella IgM Substrate Slide MOL9026 C. difficile Primer Pair MOL9036 B. holmesii Primer Pair MOL9400 C. pneumoniae II Primer Pair MOL9311 Adenovirus 3' Hexon Primer Pair QMOL9305 Exogenous DNA II Primer Pair MOL9312 Adenovirus 5' Hexon Primer Pair MOL9062 A. phagocytophilum Primer Pair MOL9315 Borrelia Primer Pair MOL9637 HSV-1 (TAMRA) Primer Pair MOL9773 Prothrombin (FII) HyBeacon Gen II MOL9607 B. parapertussis (TAMRA) Primer Pair MOL9064 Ehrlichia Primer Pair MOL9099 HHV-8 Primer Pair MOL9063 Babesia Primer Pair MOL9231 Exogenous RNA Primer Pair MOL9319 Parvovirus Primer Pair MOL9401 Legionella Primer Pair MOL9065 Plasmodium Primer Pair MOL9066 Bartonella Primer Pair MOL9775 MTHFR 677 HyBeacon Gen II MOL9321 JCV Primer Pair MOL9081 JCV Gen II Primer Pair MOL9771 Factor V Leiden HyBeacon Gen II MOL9777 MTHFR 1298 HyBeacon Gen II MOL9069 BKV Gen II Primer Pair MOL9059 C. auris Primer Pair MOL9202 Monkeypox Primer Pair MOL9178 Human GAPDH Endogenous Primer Pair MOL9203 Borrelia miyamotoi Primer Pair MOL9207 Measles Virus Primer Pair MOL9050 Factor V Leiden Mutant Primer Pair MOL9029 hMPV Primer Pair MOL9002 CMV Primer Pair MOL9012 ADENOVIRUS 5' HEXON PRIMER PAIR MOL9041 Dengue Virus 1 Primer Pair MOL9030 Parainfluenza 1 Primer Pair

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GQC Antisera, Cf, Equine Encephalitis Virus, Eee, Wee Microbiology Class 1 866.3240 2007-12-21
MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown Class 3 N/A 2013-01-28
PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology Class 2 866.3180 2013-01-28
PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays Microbiology Class 2 866.3920 2019-12-10
PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples Microbiology Class 2 866.3309 2019-12-10
MGM C. Trachomatis (Chlamydia Group) Microbiology Class 1 866.3120 2013-01-30
LIB Device, General Purpose, Microbiology, Diagnostic Microbiology Class 1 866.2660 1999-02-03
OTT Research Use Only/Microbiology Unknown Class N N/A 2013-05-29
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2010-11-01
MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Microbiology Class 2 866.3305 2007-12-21
NOP Elisa, Antibody, West Nile Virus Microbiology Class 2 866.3940 2007-12-21
SBT Device To Detect Microbial Colonization Directly From Clinical Specimens. Microbiology Class 2 866.3967 2024-07-18
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-04-27
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2023-04-10
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2023-04-10
GPJ Antiserum, Fluorescent, Q Fever Microbiology Class 1 866.3500 2017-07-10
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2018-11-19
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2018-11-19
OQO Herpes Simplex Virus Nucleic Acid Amplification Assay Microbiology Class 2 866.3305 2015-09-02
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2007-12-21
LSQ Reagent, Rickettsia Serological Microbiology Class 1 866.3500 1998-06-19
NOP Elisa, Antibody, West Nile Virus Microbiology Class 2 866.3940 2007-12-21
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2020-08-25
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2020-08-25
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2026-01-16
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2026-01-16
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2009-12-16
LKI Antisera, Fluorescent, Chlamydia Spp. Microbiology Class 1 866.3120 2008-08-15
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2007-12-21
OSU Dengue Serological Reagents Microbiology Class 2 866.3945 2013-01-29
GQC Antisera, Cf, Equine Encephalitis Virus, Eee, Wee Microbiology Class 1 866.3240 2003-05-08
QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna Microbiology Class 2 866.3183 2021-08-10
GQC Antisera, Cf, Equine Encephalitis Virus, Eee, Wee Microbiology Class 1 866.3240 2007-12-21
OMN C. Difficile Nucleic Acid Amplification Test Assay Microbiology Class 1 866.2660 2012-04-10
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2016-01-15
PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System Microbiology Class 2 866.3970 2019-05-22
OZZ Bordetella Pertussis Dna Assay System Microbiology Class 2 866.3980 2018-08-23
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2018-08-23
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-07-06
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Microbiology Class 1 866.3740 2018-09-14
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2009-04-10

Official Correspondent

Mari Meyer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DiaSorin Molecular LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

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Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2022 Abbott Molecular, Inc. N
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Z-0005-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2023365. Last updated year: 2026. Please use registration number 2023365 when referencing this establishment in official correspondence.
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