FDA Registration
Active
🇺🇸 United States
DiaSorin Molecular LLC
Reg #: 2023365
·
FEI: 2023365
·
Expires 2026
Products
41
Proprietary Names
219
Establishment Types
3
Classifications
41
Registration Details
- Registration Name
- DiaSorin Molecular LLC
- Registration Number
- 2023365
- FEI Number
- 2023365
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11331 Valley View St
- City
- CYPRESS
- State
- CA
- ZIP
- 90630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K913617
Owner / Operator
- Firm Name
- DiaSorin Molecular LLC
- Operator Number
- 9089763
- Address
- 11331 Valley View Street, --
- City
- Cypress
- State
- CA
- Postal Code
- 90630
- Country
- US
- Correspondent
- Mari Meyer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, Cf, Equine Encephalitis Virus, Eee, Wee | GQC | Class 1 | Microbiology | No | 2007-12-21 |
| Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg | MYL | Class 3 | Unknown | No | 2013-01-28 |
| Cytomegalovirus (Cmv) Dna Quantitative Assay | PAB | Class 2 | Microbiology | No | 2013-01-28 |
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | Class 2 | Microbiology | No | 2019-12-10 |
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | Class 2 | Microbiology | No | 2019-12-10 |
| C. Trachomatis (Chlamydia Group) | MGM | Class 1 | Microbiology | No | 2013-01-30 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 1999-02-03 |
| Research Use Only/Microbiology | OTT | Class N | Unknown | No | 2013-05-29 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2010-11-01 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | MYF | Class 2 | Microbiology | No | 2007-12-21 |
| Elisa, Antibody, West Nile Virus | NOP | Class 2 | Microbiology | No | 2007-12-21 |
| Device To Detect Microbial Colonization Directly From Clinical Specimens. | SBT | Class 2 | Microbiology | No | 2024-07-18 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-04-27 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2023-04-10 |
| Antiserum, Fluorescent, Q Fever | GPJ | Class 1 | Microbiology | No | 2017-07-10 |
| Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | NJR | Class 1 | Microbiology | No | 2018-11-19 |
| Herpes Simplex Virus Nucleic Acid Amplification Assay | OQO | Class 2 | Microbiology | No | 2015-09-02 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2007-12-21 |
| Reagent, Rickettsia Serological | LSQ | Class 1 | Microbiology | No | 1998-06-19 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2020-08-25 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2009-12-16 |
| Antisera, Fluorescent, Chlamydia Spp. | LKI | Class 1 | Microbiology | No | 2008-08-15 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2007-12-21 |
| Dengue Serological Reagents | OSU | Class 2 | Microbiology | No | 2013-01-29 |
| Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna | QLX | Class 2 | Microbiology | No | 2021-08-10 |
| C. Difficile Nucleic Acid Amplification Test Assay | OMN | Class 1 | Microbiology | No | 2012-04-10 |
| Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | PLO | Class 2 | Microbiology | No | 2019-05-22 |
| Bordetella Pertussis Dna Assay System | OZZ | Class 2 | Microbiology | No | 2018-08-23 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-07-06 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2009-04-10 |
| Antigen, B. Pertussis | GOX | Class 1 | Microbiology | No | 2008-02-07 |
| Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | PGX | Class 2 | Microbiology | No | 2015-07-13 |
| Internal Polymerase Chain Reaction Control, Not Assay Specific | OLD | Class 1 | Clinical Chemistry | No | 2009-12-16 |
| Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm | MYM | Class 3 | Unknown | No | 2013-01-28 |
| Antiserum, Typhus Fever | GPN | Class 1 | Microbiology | No | 2007-12-21 |
| Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | PGH | Class 2 | Microbiology | No | 2014-05-05 |
| C. Difficile Toxin Gene Amplification Assay | OZN | Class 2 | Microbiology | No | 2017-02-15 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2008-01-25 |
| Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection | QDZ | Class 2 | Microbiology | No | 2023-06-14 |
| Anti-Jcv Antibody Detection Assay | OYP | Class 2 | Microbiology | No | 2014-08-20 |
| Antigen, Cf (Including Cf Control), Epstein-Barr Virus | GNQ | Class 1 | Microbiology | No | 2021-08-10 |
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 SimplexaGroup 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
Simplexa Bordetella pertussis / parapertussis
IF0200M Q Fever IFA IgM Kit
MOL2850 Simplexa Group A Strep Direct
MOL2860 Group A Strep Positive Control Pack
MOL9000 SIMPLEXA EXTRACTION & AMPLIFICATION CONTROL SET
SC1100 Simplexa Spectral Calibration Panel
MOL9300 Simplexa Extraction & Amplification Control Set
MOL9200 SIMPLEXA EXTRACTION & AMPLIFICATION CONTROL SET - RNA
EL0100M - Parvovirus B19 DxSelect IgM Kit
MOL4450 Simplexa COVID-19 / Flu A/B & RSV Direct
MOL4460 Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack
IF0100G/IF0100M Rickettsia IFA IgG Kit & Rickettsia IFA IgM Kit
MOL2150 Simplexa HSV 1 & 2 Direct
MOL2160 Simplexa HSV 1 & 2 Positive Control Pack
MOL2950 Simplexa C. difficile Direct
MOL5290 Simplexa C. difficile Positive Control Pack
MOL2960 Simplexa C. difficile Positive Control Pack
MOL9070 TA Master Mix (Temperature Activated)
MOL9060G HS Master Mix
IF0006 YOLK SAC DILUENT
MOL9018 REVERSE TRANSCRIPTASE
MOL9310 2.5X Universal Master Mix (860 uL)
EL1826 Streptavidin HRP Conjugate
IF0001-3 IFA IgG Conjugate
MOL9370 TA Master Mix
MOL2304 Exogenous RNA
MOL9090 Fungal Lysis Solution
IF1209 DUAL SPECIES IgA CONJUGATE
MOL9010 2.5 X UNIVERSAL MASTER MIX
MOL2265 - Simplexa Congenital CMV Positive Control Pack
MOL2255 - Simplexa Congenital CMV Direct
EL1950 STRATIFY JCV® DxSelect
EL1950-5 STRATIFY JCV® DxSelect
MOL2185 Simplexa HSV 1/2 & VZV Universal Direct
MOL2175 Simplexa HSV 1/2 & VZV Universal Direct
MOL2410 Simplexa EBV Quantitation Standards
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility