FDA Registration
Active
🇺🇸 United States
Ortho-Clinical Diagnostics, Inc.
Reg #: 1528450
·
FEI: 1000122536
·
Expires 2026
Products
47
Proprietary Names
88
Establishment Types
5
Classifications
47
Registration Details
- Registration Name
- Ortho-Clinical Diagnostics, Inc.
- Registration Number
- 1528450
- FEI Number
- 1000122536
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2005 East State Street, Suite 100
- City
- ATHENS
- State
- OH
- ZIP
- 45701
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232286
Owner / Operator
- Firm Name
- QuidelOrtho Corporation
- Operator Number
- 2024674
- Address
- 9975 Summers Ridge Road
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | Class 2 | Microbiology | No | 2024-01-26 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2024-01-26 |
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | Class 2 | Microbiology | No | 2024-01-26 |
| Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | GQN | Class 2 | Microbiology | No | 2022-12-20 |
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2022-12-21 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2022-12-21 |
| Quality Control Slides | LJG | Class 1 | Microbiology | No | 2022-12-20 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2022-12-20 |
| Antisera, Cf, Influenza Virus A, B, C | GNW | Class 1 | Microbiology | No | 2022-12-20 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2022-12-20 |
| Antisera, Conjugated Fluorescent, Cytomegalovirus | LIN | Class 2 | Microbiology | No | 2022-12-20 |
| Cells, Animal And Human, Cultured | KIR | Class 1 | Hematology | No | 2022-12-20 |
| Antisera, Fluorescent, Adenovirus 1-33 | GNY | Class 1 | Microbiology | No | 2022-12-20 |
| Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | GQS | Class 1 | Microbiology | No | 2022-12-20 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2022-12-21 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2026-04-20 |
| Antisera, Fluorescent, Human Metapneumovirus | OMG | Class 2 | Microbiology | No | 2022-12-20 |
| Respiratory Syncytial Virus, Antigen, Antibody, Ifa | LKT | Class 1 | Microbiology | No | 2022-12-20 |
| Antisera, Hai, Influenza Virus A, B, C | GNS | Class 1 | Microbiology | No | 2022-12-20 |
| Complement C1q, Antigen, Antiserum, Control | DAK | Class 2 | Immunology | No | 2012-02-29 |
| Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | PGX | Class 2 | Microbiology | No | 2022-12-21 |
| C. Difficile Toxin Gene Amplification Assay | OZN | Class 2 | Microbiology | No | 2022-12-21 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2024-04-02 |
| Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | GNM | Class 1 | Microbiology | No | 2022-12-20 |
| Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | QLT | Class N | Unknown | No | 2022-05-09 |
| Antiserum, Fluorescent, Chlamydia Trachomatis | LJP | Class 1 | Microbiology | No | 2022-12-20 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2022-12-21 |
| Column Chromatography & Color Development, Hydroxyproline | JMM | Class 1 | Clinical Chemistry | No | 2008-08-08 |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | Class 1 | Hematology | No | 2022-12-20 |
| Bordetella Pertussis Dna Assay System | OZZ | Class 2 | Microbiology | No | 2022-12-21 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2022-12-21 |
| Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | NJR | Class 1 | Microbiology | No | 2022-12-21 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2022-12-20 |
| Antisera, Fluorescent, Poliovirus 1-3 | GOE | Class 1 | Microbiology | No | 2022-12-20 |
| Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | DBA | Class 2 | Immunology | No | 2012-02-29 |
| Antisera, Fluorescent, Echovirus 1-34 | GRK | Class 1 | Microbiology | No | 2022-12-20 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2022-12-21 |
| Factor B, Antigen, Antiserum, Control | JZH | Class 2 | Immunology | No | 2012-02-29 |
| Antigen, C. Difficile | MCB | Class 1 | Microbiology | No | 2022-12-21 |
| Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | CIN | Class 2 | Clinical Chemistry | No | 2008-08-08 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2022-12-20 |
| Complement C1s, Antigen, Antiserum, Control | CZY | Class 2 | Immunology | No | 2012-02-29 |
| Antisera, Fluorescent, Herpesvirus Hominis 1,2 | GQL | Class 2 | Microbiology | No | 2022-12-20 |
| Formulations, Balanced Salt Solutions | KIP | Class 1 | Hematology | No | 2022-12-20 |
| Antigen, Cf, (Including Cf Control), Varicella-Zoster | GQW | Class 2 | Microbiology | No | 2022-12-20 |
| Complement C9, Antigen, Antiserum, Control | DAE | Class 2 | Immunology | No | 2012-02-29 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
Proprietary Names
Savanna HSV 1+2/VZV Control Set
Savanna Instrument
Savanna HSV 1+2/VZV Assay
ELVIS HSV
Lyra RSV+hMPV Assay
D3 Control Slides
Thyretain TSI Reporter Bioassay
Solana RSV+hMPV Assay, M306
D3 Duet DFA Influenza A/Respiratory
Quidel Digital Heat Block
D3 DFA Cytomegalovirus Immediate EA
Cultured Cells - Animal and Human
D3 Fastpoint L-DFA Parainfluenza Virus/Adenovirus Identifica
Lyra Parainfluenza Virus Assay
NuLexa Influenza + SARS Test
NuLexa Instrument
D3 DFA Metapneumovirus Identificati
D3 Ultra Duet DFA Respiratory Virus
Lyra Adenovirus Assay
MicroVue CIC-C1q EIA
D3 Ultra DFA Respiratory Virus Scre
Lyra Direct Strep Assay
Solana C.difficile Assay
Walgreens At-Home COVID-19 Test Kit
QuickVue COVID-19 Test
CVS Health At Home COVID-19 Test Kit
Diagnostic Hybrids D3 DFA Herpes S
D3 IFA Enterovirus
Lyra Direct C.difficile Assay
Lyra Rapid DNA Stool Sample Prep Kit
Savanna RVP4 Assay
Diagnostic Hybrids D3 DFA Chlamydi
Solana Trichomonas Assay
Solana Trichomonas Swap Assay (M304.S)
Solana Trichomonas Urine Assay (M304.U)
MicroVue DPD
Turbo Treat
Solana Bordetella Complete Assay
Lyra SARS-CoV-2 Assay (EUA200016)
Solana SARS-CoV-2 Assay (EUA203087)
Lyra Direct SARS-CoV-2 Assay (EUA200423)
Solana HSV 1+2/VZV Assay
Savanna RVP Control Set
D3 Fastpoint L-DFA RSV/MPV Identification Kit
D3 Fastpoint L-DFA Influenza A/INFL
Solana GBS Assay
MicroVue PYD
D3 Duet DFA RSV/Respiratory Virus S
Viropak
D3 IFA-DFA Enterovirus
MicroVue C1 Inhibitor Plus EIA
Solana Strep Complete Assay
Solana Influenza A+B Assay
MicroVue Bb Plus
Lyra Influenza A+B Assay
Clostridium difficile Toxin, Reagents for Cytotoxicity Assay
MicroVue BAP
Solana GAS Assay
Solana Instrument
Mounting Fluid
MicroVue CIC-Raji Cell Replacement EIA
ELVIS HSV ID and D3 Typing Test SYS
HBSS
Balanced Salt Solution
Quidel Thyretain Turbo TSI Reporter BioAssay
Diagnostic Hybrids D3 DFA Varicella
MicroVue CH50 Eq EIA
Lyra Direct HSV 1+2/VZV Assay
Quidel Molecular GBS Control Set (M116)
VITROS HIV Combo Controls (HIV p24 Antigen)
Solana RSV+hMPV Control Set (M123)
Quidel Molecular RSV+hMPV Control Set (M107)
Solana Influenza A+B Control Set (M122)
VITROS Anti-HIV 1+2 Controls
Quidel Molecular Adenovirus Control Set (M110)
Quidel Molecular Strep A+G Control Set (M111)
QuickVue COVID-19 Test Control Swab Set
Quidel Molecular Bordetella Control Set (M117)
Quidel Molecular Influenza A+B Control Set (M106)
Quidel Molecular HSV 1+2/VZV Control Set (M121)
Quidel Molecular C. difficile Control Set (M108)
Solana HSV 1+2/VZV Control Set (M118)
VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2)
Quidel Molecular Parainfluenza Virus Control Set (M115)
VITROS HIV Combo Controls (Anti-HIV-1 group O)
Quidel Molecular HSV 1+2 Control Set (M109)
Quidel Molecular Trichomonas Control Set (M119)
MicroVue CIC-C1q Controls
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility