Ortho-Clinical Diagnostics

FDA Device Registration & Listing · Pencoed Bridgend, GB · Registration 3007111389

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007111389
FEI Number
3007111389
Entity Name
Ortho-Clinical Diagnostics
City/State/Country
Pencoed Bridgend, GB
Establishment Address
Felindre Meadows, Pencoed Bridgend CF35 5PZ, GB
Establishment Type(s)
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
N
Expiration Date (Year)
2026
510(k) Number
K171168
PMA Number
N/A

All Registered Proprietary Names

VITROS Total PSA Range Verifier VITROS INTACT PTH Controls VITROS B12 Range Verifier VITROS CA 125 II Range Verifier VITROS Cortisol Range Verifier VITROS CA 15-3 Range Verifier VITROS Metabolism Controls VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers VITROS AFP Range Verifier VITROS Folate Range Verifier VITROS Immunodiagnostic Products hs Troponin I Low Control VITROS Immunodiagnostic Products CA 19-9 Reagent Pack VITROS Anti-HAV IgM Calibrator VITROS Anti-HAV IgM Controls VITROS Anti-HAV IgM Reagent Pack VITROS MicroSensor Check Fluids VITROS 7% BSA Ortho 7% BSA VITROS Signal Reagent VITROS Reference Fluids VITROS High Sample Diluent A and B VITROS Immuno-Wash Fluid VITROS FS Reconstitution Diluent VITROS Universal Wash Reagent VITROS Urine Electrolyte Diluent VITROS FS Diluent Pack 1, 2, 3 and 4 VITROS Calibrator Kit 27 VITROS Calibrator Kit 16 VITROS Immunodiagnostic Products CA 19-9 Calibrator VITROS Total bhCG II Range Verifier VITROS Total bhCG II Reagent Pack VITROS Total bhCG II Calibrator VITROS CEA Calibrators VITROS CEA Reagent Pack VITROS CEA Range Verifier VITROS Anti-HBc IgM Controls VITROS CA 19-9 Range Verifiers VITROS CA 19-9 Calibrator VITROS CA 19-9 Reagent Pack VITROS FSH Calibrator VITROS FSH Reagent Pack VITROS HBeAg Calibrator VITROS HBeAg Reagent Pack VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls DEN210040 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack DEN210040 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040 VITROS TSH Calibrator VITROS TSH Reagent Pack VITROS 3600 Immunodiagnostics System - Certified VITROS TSH Range Verifier VITROS 3600 Immunodiagnostics System VITROS 3600 Immunodiagnostics System - Refurbished VITROS 25-OH Vitamin D Total Reagent Pack VITROS 25-OH Vitamin D Total Calibrators VITROS Total PSA Calibrator VITROS Total PSA Reagent Pack VITROS Testosterone Range Verifier VITROS Testosterone Reagent Pack VITROS Testosterone Calibrator VITROS Total T3 II Reagent Pack VITROS Total T3 II Calibrator VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack VITROS Anti-HAV Total Calibrators VITROS Anti-HAV Total Controls VITROS Anti-HAV Total Reagent Pack VITROS Anti-SARS-CoV-2 IgG Calibrator VITROS Anti-SARS-CoV-2 IgG Reagent Pack VITROS Anti-SARS-CoV-2 IgG Controls VITROS NTx Range Verifier VITROS LH Reagent Pack VITROS LH Calibrator VITROS Free Thyroid Controls VITROS Total Thyroid Controls VITROS Testosterone Controls VITROS RE Controls VITROS Anemia Controls VITROS Anti-HBs Quantitative Controls VITROS NT pro-BNP Reagent Pack VITROS NT pro-BNP Range Verifier VITROS NT pro-BNP Calibrators VITROS T3 Uptake II Range Verifier VITROS FSH Range Verifier VITROS Progesterone Range Verifier VITROS LH Range Verifier VITROS Total T3 II Range Verifier VITROS Total T4 Range Verifier VITROS Prolactin Range Verifier VITROS Free T3 Range Verifier VITROS Troponin I ES Calibrators VITROS Troponin I ES Reagent Pack VITROS Troponin I ES Range Verifier 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) VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack VITROS NT-proBNP II Reagent Pack VITROS Anti-HBc IgM Calibrator VITROS Anti-HBc IgM Reagent Pack VITROS HBsAg Controls VITROS INTACT PTH Calibrators VITROS INTACT PTH Reagent Pack VITROS INTACT PTH Range Verifier VITROS CK-MB Range Verifier VITROS Estradiol Range Verifier VITROS Free T4 Range Verifier VITROS Ferritin Range Verifier VITROS Estradiol Calibrator VITROS Estradiol Reagent Pack VITROS Immunodiagnostic Products hs Troponin I Low Control VITROS Immunodiagnostic Products hs Troponin I Calibrator VITROS Immunodiagnostic Products hs Troponin I Reagent Pack VITROS Total T4 Calibrator VITROS Total T4 Reagent Pack VITROS Anti-HBc Controls VITROS Myoglobin Reagent Pack VITROS Myoglobin Range Verifier VITROS Myoglobin Calibrator VITROS T3 Uptake II Calibrator VITROS T3 Uptake II Reagent Pack VITROS Immunodiagnostic Products hsTroponin I Calibrator VITROS Calibrator Kit 25 VITROS Immunodiagnostic Products Progesterone 2 Calibrators VITROS Anti-HCV Calibrators VITROS Anti- HCV Reagent Pack VITROS AFP Reagent Pack VITROS AFP Calibrators VITROS HIV Combo Calibrator VITROS HIV Combo Reagent Pack VITROS Rubella IgG Calibrator VITROS Rubella IgG Reagent Pack VITROS CK-MB Calibrator VITROS CK-MB Reagent Pack VITROS Anti-HCV Controls VITROS Anti-HIV 1+2 Calibrator VITROS Anti-HIV 1+2 Reagent Pack VITROS B12/Folate Reagent Pack 1/2 VITROS B12 Calibrator VITROS B12/Folate Reagent Pack 3 VITROS Insulin Calibrator VITROS Insulin Reagent Pack

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-21
NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Immunology Class 2 866.6010 2024-04-02
LOL Hepatitis A Test (Antibody And Igm Antibody) Microbiology Class 2 866.3310 2022-12-21
PPM General Purpose Reagent Pathology Class 1 864.4010 2022-12-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2023-02-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-21
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2022-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-21
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2022-12-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-09
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2023-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-09
NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Immunology Class 2 866.6010 2023-01-09
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2022-12-21
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2022-12-21
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2023-01-09
QVP Sars-Cov-2 Serology Test Microbiology Class 2 866.3983 2023-08-21
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2022-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-21
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2022-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2023-01-09
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2023-01-09
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2023-01-09
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2022-12-21
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2022-12-21
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2022-12-21
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2022-12-21
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2024-06-28
LOL Hepatitis A Test (Antibody And Igm Antibody) Microbiology Class 2 866.3310 2022-12-21
QVP Sars-Cov-2 Serology Test Microbiology Class 2 866.3983 2023-05-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2023-01-09
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2022-12-21
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2022-12-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-21
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2022-12-21
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2023-01-09
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2022-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-21
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2022-12-21
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2025-05-14
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2025-03-25
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2023-01-09
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2023-01-09
MJX Kit, Serological, Positive Control Clinical Chemistry Class 1 862.1660 2023-01-09
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-21
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2022-12-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-09
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2022-12-21
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2022-12-21
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2025-11-26
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2022-12-21
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2022-12-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-21
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2022-12-21
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2022-12-21
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2023-01-25
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2022-12-19
MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology Class 2 866.3169 2023-01-09
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer Immunology Class 2 866.6010 2022-12-21
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2023-07-11
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2022-12-21
JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2022-12-21
MJX Kit, Serological, Positive Control Clinical Chemistry Class 1 862.1660 2023-01-09
MJY Kit, Serological, Negative Control Clinical Chemistry Class 1 862.1660 2023-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-09
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2023-07-11
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2022-12-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2022-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

Raquel Almeida Business: Ortho-Clinical Diagnostics, Inc. Email: orthocompliance@quidelortho.com Phone: (908) 7046825

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
1528450 Ortho-Clinical Diagnostics, Inc. ATHENS, OH, US
2024674 QUIDEL CORP. SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2015 Ortho-Clinical Diagnostics 2
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007111389. Last updated year: 2026. Please use registration number 3007111389 when referencing this establishment in official correspondence.
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