Data / Medical devices / United States / Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc.: FDA-registered device maker in Athens, OH, United States, 45 510(k) clearances
Ortho-Clinical Diagnostics, Inc. is registered with the FDA (registration 1528450) in Athens, OH, United States. It lists 47 device types. The FDA files 45 510(k) clearances under its listings, the newest dated February 13, 2026. 10 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1528450
- FEI number
- 1000122536
- Address
- 2005 East State Street, Suite 100, Athens, OH, United States, 45701
- Owner or operator
- QuidelOrtho Corporation (2024674)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- August 8, 2008
- Registered through
- 2026
- Brand names listed
- Balanced Salt Solution, CVS Health At Home COVID-19 Test Kit, Clostridium difficile Toxin, Reagents for Cytotoxicity Assay, Cultured Cells - Animal and Human, D3 Control Slides, D3 DFA Cytomegalovirus Immediate EA, D3 DFA Metapneumovirus Identificati, D3 Duet DFA Influenza A/Respiratory and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2026 | K251742 | VELO Respiratory Test | QOF | Substantially Equivalent | Lex Diagnostics Limited | accessdata.fda.gov |
| March 22, 2024 | K231795 | QuickVue COVID-19 Test | QYT | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| December 20, 2023 | K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | PGI | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| July 15, 2018 | K181029 | Solana Bordetella Complete Assay | OZZ | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| December 21, 2017 | K173250 | Solana GBS Assay | NJR | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| October 16, 2017 | K171974 | Solana RSV+hMPV Assay | OCC | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| May 11, 2017 | K170491 | Solana C. difficile Assay | OZN | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| November 28, 2016 | K162451 | Solana HSV 1+2/VZV Assay | PGI | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| October 25, 2016 | K162274 | Solana Strep Complete Assay | PGX | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| September 27, 2016 | K161814 | Solana Influenza A+B Assay | OCC | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| August 15, 2016 | K161182 | Solana Trichomonas Assay | OUY | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| June 23, 2015 | K150868 | Solana GAS Assay, Solana instrument | PGX | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| October 9, 2014 | K141931 | LYRA ADENOVIRUS ASSAY | OCC | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| October 9, 2014 | K141927 | LYRA PARAINFLUENZA VIRUS ASSAY | OOU | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| May 13, 2014 | DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | PGI | Unknown | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| April 16, 2014 | DEN140005 | LYRA DIRECT STREP ASSAY | PGX | Unknown | Quidel Corporation | accessdata.fda.gov |
| September 6, 2013 | K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | OCC | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| August 29, 2013 | K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | OZE | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| March 8, 2013 | K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | OZN | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| May 18, 2010 | K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | JZO | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| December 23, 2009 | K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | GQS | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| December 4, 2009 | K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | OMG | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| October 21, 2009 | K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | GNW | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| September 11, 2009 | K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | OMG | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| August 28, 2009 | K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | GNW | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| August 28, 2009 | K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | GQL | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| March 6, 2009 | K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | OMG | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| December 23, 2008 | K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | LKT | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| December 23, 2008 | K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | GNW | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| June 13, 2008 | K081164 | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT | LIN | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| October 24, 2007 | K070265 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 | GQN | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| September 24, 2007 | K063675 | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT | LJP | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| September 21, 2007 | K063798 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 | GQN | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| August 30, 2007 | K070206 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | GQW | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| November 20, 2006 | K061101 | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | GNW | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| August 13, 1998 | K981364 | PYRILINKS-D ASSAY KIT | JMM | Substantially Equivalent | Metra Biosystems, Inc. | accessdata.fda.gov |
| July 29, 1998 | K974111 | QUIDEL CH50 EQ EIA | DAE | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| May 27, 1998 | K981373 | ALKPHASE-B ASSAY KIT | CIN | Substantially Equivalent | Metra Biosystems, Inc. | accessdata.fda.gov |
| November 3, 1995 | K952026 | PYRILINKS POLYCLONAL ASSAY KIT | JMM | Substantially Equivalent | Metra Biosystems, Inc. | accessdata.fda.gov |
| May 1, 1995 | K941924 | ELVIS HSV | GQN | Substantially Equivalent | Diagnostic Hybrids, Inc. | accessdata.fda.gov |
| August 4, 1988 | K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | DAK | Substantially Equivalent | Cytotech, Inc. | accessdata.fda.gov |
| November 25, 1987 | K874379 | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY | CZY | Substantially Equivalent | Cytotech, Inc. | accessdata.fda.gov |
| July 23, 1987 | K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | DBA | Substantially Equivalent | Cytotech, Inc. | accessdata.fda.gov |
| September 4, 1986 | K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | DAK | Substantially Equivalent | Cytotech, Inc. | accessdata.fda.gov |
| May 21, 1984 | K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | MCB | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 1, 2023 | 91772 | Class II | Ongoing | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above | Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert. | accessdata.fda.gov |
| August 13, 2021 | 88498 | Class II | Terminated | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), naso | Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roc | accessdata.fda.gov |
| April 27, 2021 | 87996 | Class I | Terminated | Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent | In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have | accessdata.fda.gov |
| April 4, 2017 | 79629 | Class II | Terminated | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture im | There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay. | accessdata.fda.gov |
| October 26, 2016 | 79595 | Class III | Terminated | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. | There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay. | accessdata.fda.gov |
| July 14, 2016 | 79621 | Class II | Terminated | MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum. | There is a possibility of low volume and/or leaking standard bottles. | accessdata.fda.gov |
| November 3, 2015 | 79642 | Class III | Terminated | MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) | A component of the kit was found to contain bacterial contamination. | accessdata.fda.gov |
| October 16, 2014 | 69545 | Class II | Terminated | MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic. | Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented. | accessdata.fda.gov |
| December 31, 2012 | 64115 | Class III | Terminated | Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus | RhMK product fungal contamination. | accessdata.fda.gov |
| January 21, 2009 | 53702 | Not yet classified | Terminated | Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk', 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product is packed in glass cultur | During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells). | accessdata.fda.gov |
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Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.