Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1528450

FEI Number

1000122536

Entity Name

Ortho-Clinical Diagnostics, Inc.

City/State/Country

ATHENS, OH, US

Establishment Address

2005 East State Street, Suite 100, ATHENS, OH 45701, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

QuidelOrtho Corporation (Owner Number: 2024674)

Owner / Operator Contact Address

9975 Summers Ridge Road, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 D3 IFA-DFA Enterovirus Solana Influenza A+B Assay MicroVue Bb Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2024-01-26
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-01-26
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2024-01-26
GQN	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2022-12-20
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2022-12-21
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2022-12-21
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2022-12-20
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2022-12-20
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2022-12-21
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2022-12-20
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2022-12-20
LIN	Antisera, Conjugated Fluorescent, Cytomegalovirus	Microbiology	Class 2	866.3175	2022-12-20
KIR	Cells, Animal And Human, Cultured	Hematology	Class 1	864.2280	2022-12-20
GNY	Antisera, Fluorescent, Adenovirus 1-33	Microbiology	Class 1	866.3020	2022-12-20
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2022-12-20
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2022-12-21
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2026-04-20
OMG	Antisera, Fluorescent, Human Metapneumovirus	Microbiology	Class 2	866.3980	2022-12-20
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Microbiology	Class 1	866.3480	2022-12-20
OMG	Antisera, Fluorescent, Human Metapneumovirus	Microbiology	Class 2	866.3980	2022-12-20
GNY	Antisera, Fluorescent, Adenovirus 1-33	Microbiology	Class 1	866.3020	2022-12-20
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	Microbiology	Class 1	866.3400	2022-12-20
GNS	Antisera, Hai, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2022-12-20
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2022-12-21
DAK	Complement C1q, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2012-02-29
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2022-12-20
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2022-12-21
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-12-21
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2022-12-21
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-04-02
GQN	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2022-12-20
GNM	Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6	Microbiology	Class 1	866.3145	2022-12-20
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2022-12-21
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-12-21
QLT	Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	Unknown	Class N	N/A	2022-05-09
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	Microbiology	Class 1	866.3120	2022-12-20
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2022-12-21
JMM	Column Chromatography & Color Development, Hydroxyproline	Clinical Chemistry	Class 1	862.1400	2008-08-08
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2022-12-20
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	Class 2	866.3980	2022-12-21
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2022-12-21
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2022-12-21
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2024-12-16
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Microbiology	Class 1	866.3480	2022-12-20
OMG	Antisera, Fluorescent, Human Metapneumovirus	Microbiology	Class 2	866.3980	2022-12-20
GNW	Antisera, Cf, Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2022-12-20
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2022-12-21
JMM	Column Chromatography & Color Development, Hydroxyproline	Clinical Chemistry	Class 1	862.1400	2008-08-08
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Microbiology	Class 1	866.3480	2022-12-20
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2022-12-20
GOE	Antisera, Fluorescent, Poliovirus 1-3	Microbiology	Class 1	866.3405	2022-12-20
DBA	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control	Immunology	Class 2	866.5250	2012-02-29
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2022-12-21
GRK	Antisera, Fluorescent, Echovirus 1-34	Microbiology	Class 1	866.3205	2022-12-20
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-12-21
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2022-12-21
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2022-12-21
JZH	Factor B, Antigen, Antiserum, Control	Immunology	Class 2	866.5320	2012-02-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QuidelOrtho Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1056600	MICRO TYPING SYSTEMS, INC.	POMPANO BEACH, FL, US
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
2024674	QUIDEL CORP.	SAN DIEGO, CA, US
3012963943	Ortho Clinical Diagnostics, K.K.	Shinagawa-ku Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K000362	Zeus Scientific, Inc.	MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM	2000-02-18
K250250	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Anti-Thyroid Peroxidase II	2025-10-17
K152061	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material	2016-03-03
K780273	Flow Laboratories, Inc.	INFLUENZA HI PRESERUM	1978-02-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0043-2025	Luminex Molecular Diagnostics Inc	N	NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Z-0039-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	1	IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 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 1528450. Last updated year: 2026. Please use registration number 1528450 when referencing this establishment in official correspondence.