FDA Registration
Active
🇺🇸 United States
Ortho-Clinical Diagnostics, Inc.
Reg #: 3021090658
·
FEI: 3021090658
·
Expires 2026
Products
21
Proprietary Names
63
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- Ortho-Clinical Diagnostics, Inc.
- Registration Number
- 3021090658
- FEI Number
- 3021090658
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2285 Rutherford Road
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173496
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 |
|---|---|---|---|---|---|
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2018-08-31 |
| Assayed Quality Control Material For Clinical Microbiology Assays | QCH | Class 2 | Microbiology | No | 2018-08-31 |
| Antisera, All Groups, Streptococcus Spp. | GTZ | Class 1 | Microbiology | No | 2008-08-08 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-12-21 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2020-11-24 |
| Over-The-Counter Covid-19 Antigen Test | QYT | Class 2 | Microbiology | No | 2024-04-02 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2014-01-15 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2008-08-08 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2008-08-08 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2017-03-23 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-24 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | Class 2 | Microbiology | No | 2023-03-16 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | Class 1 | Microbiology | No | 2017-06-02 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2012-02-28 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2021-12-15 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2005-12-01 |
| Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | LHL | Class 2 | Microbiology | No | 2012-12-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2008-08-08 |
| Mmp-9 Test System | PFQ | Class 1 | Clinical Chemistry | No | 2017-06-02 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 2021-12-09 |
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2021-12-01 |
Proprietary Names
Sofia 2 Lyme FIA
QuickVue In-Line Strep A
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)
Sofia 2 Flu + SARS Antigen FIA
Walgreens At-Home COVID-19 Test Kit
QuickVue COVID-19 Test
CVS Health At Home COVID-19 Test Kit
QuickVue RSV Test
QuickVue hCG Urine Test
QuickVue Dipstick Strep A
QuickVue+ Strep A
Sofia 2
Sofia 2 Installation Pack
QuickVue+ hCG Combo Test
QuickVue At Home COVID-19
Sofia SARS Antigen FIA
Sofia 2 SARS Antigen FIA
QuickVue SARS Antigen Test
VITROS SARS-COV-2 Antigen Reagent Pack EUA202928
VITROS SARS-COV-2 Antigen Calibrator EUA202928
VITROS SARS-COV-2 Antigen Controls EUA202928
VITROS SARS-COV-2 Extraction Buffer EUA202928
QuickVue hCG Combo Test
Sofia 2 SARS Antigen+ FIA
Sofia 2 SARS Antigen+ FIA Control Swab Set
QuickVue Adenoviral conjunctivitis Test
Sofia Strep A+ FIA
Sofia Installation Pack
Sofia Analyzer
Sofia Influenza A+B FIA
QuickVue In-Line Strep A Ctrl Set
QuickVue and Sofia Dry Transport Tubes
QUICKVUE IFOB TEST
Sofia hCG FIA
Sofia Legionella FIA
hCG Control Set
InflammaDry
Sofia Lyme FIA
Sofia 2 C. difficile FIA
Sofia RSV FIA
QuickVue Influenza A+B
QuickVue RSV 10
Sofia S. pneumoniae FIA
Strep A Liquid Control Set
Sofia 2 Campylobacter FIA
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Device in the United States for Export Only