Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002642396

FEI Number

3002642396

Entity Name

Ortho Clinical Diagnostics

City/State/Country

Singapore South West, SG

Establishment Address

1 International Business Park, The Synergy, #01-11/12, Singapore South West 609917, SG

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K191316

PMA Number

N/A

All Registered Proprietary Names

VITROS IgA Reagent VITROS IgG Reagent VITROS IgM Reagent VITROS Anti-HBc IgM Controls 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 VITROS PALB Performance Verifiers VITROS Calibrator Kit 23 VITROS T4 Calibrator VITROS Free T4 Reagent Pack VITROS AMPH Reagent VITROS HBsAg Controls VITROS INTACT PTH Calibrators VITROS INTACT PTH Reagent Pack VITROS INTACT PTH Range Verifier VITROS Anti-SARS-CoV-2 IgG Calibrator VITROS Anti-SARS-CoV-2 IgG Reagent Pack VITROS Anti-SARS-CoV-2 IgG Controls VITROS Calibrator Kit 17 VITROS Calibrator Kit 9 VITROS 5600 Integrated System Refurbished VITROS 5600 Integrated System VITROS PHYT Slides VITROS 5600 Integrated System Certified VITROS Calibrator Kit 13 VITROS GENT Reagent VITROS T3 Uptake II Calibrator VITROS T3 Uptake II Reagent Pack MTS Diluent 2 PLUS VITROS BuBc Slides VITROS Calibrator Kit 1 VITROS Mg Slides VITROS ACET Slides VITROS HBeAg Calibrator VITROS HBeAg Reagent Pack VITROS Anti-HBc Reagent Pack VITROS Anti-HBc Calibrator VITROS Calibrator Kit 11 VITROS VANC Reagent VITROS Immunodiagnostic Products CEA Reagent Pack VITROS Immunodiagnostic Products CEA Calibrators VITROS PALB Reagent VITROS CEA Calibrators VITROS CEA Reagent Pack VITROS CEA Range Verifier VITROS Na+ Slides VITROS CA 125 II Calibrator VITROS CA 125 II Reagent Pack ORTHO Antibody Enhancement Solution VITROS CAFFN Reagent Kit VITROS Anti-HBc Controls VITROS C3 Reagent VITROS C4 Reagent VITROS Immunodiagnostic Products hsTroponin I Calibrator VITROS Calibrator Kit 25 VITROS Immunodiagnostic Products Progesterone 2 Calibrators 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 dHDL Slides VITROS THEO Slides VITROS 25-OH Vitamin D Total Reagent Pack VITROS 25-OH Vitamin D Total Calibrators VITROS ECiQ Immunodiagnostic System VITROS ECi Immunodiagnostic System Refurbished VITROS ECi Immunodiagnostic System 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 ORTHO Workstation VITROS CK-MB Range Verifier VITROS Estradiol Range Verifier VITROS Free T4 Range Verifier VITROS Ferritin Range Verifier VITROS LDHI SLides VITROS LDH Slides VITROS FSH Calibrator VITROS FSH Reagent Pack VITROS HCY2 Reagent VITROS HCY2 Performance Verifiers VITROS Red Cell Folate Pack VITROS Folate Reagent Pack 1/2 VITROS Folate Calibrator VITROS TRFRN Reagent VITROS Protein Performance Verifiers VITROS Calibrator Kit 20 VITROS Li Slides VITROS CRP Performance Verifiers VITROS dTIBC Performance Verifiers VITROS Calibrator Kit 29 VITROS dTIBC Reagent VITROS DGXN Slides VITROS Calibrator Kit 14 VITROS TDM Performance Verifiers VITROS TOBRA Reagent VITROS Chemistry Products dHDL Slides VITROS Chemistry Products Calibrator Kit 25 VITROS Chemistry Products Performance Verifiers VITROS BRAHMS PCT Range Verifier VITROS BRAHMS PCT Calibrators VITROS BRAHMS PCT Reagent Pack VITROS BRAHMS PCT Controls VITROS PHBR Slides VITROS Calibrator Kit 8 VITROS ALC Slides VITROS Calibrator Kit 12 VITROS VALP Reagent VITROS Calibrator Kit 24 VITROS mALB Performance Verifiers VITROS mALB Reagent VITROS CA 15-3 Calibrator VITROS CA 15-3 Reagent Pack VITROS XT TRIG-CHOL Slides VITROS Myoglobin Reagent Pack VITROS Myoglobin Range Verifier VITROS Myoglobin Calibrator VITROS METD Reagent Ortho Anti A1 Lectin VITROS Cortisol Calibrator VITROS Cortisol Reagent Pack VITROS Prolactin Reagent Pack VITROS Prolactin Calibrator Ortho Optix Reader Ortho Coombs Control VITROS Liquid Performance Verifiers VITROS Anti-HBs Quantitative Reagent Pack VITROS Anti-HBs Quantitative Calibrators VITROS HBsAg Confirmatory Kit VITROS HBsAg Calibrator VITROS HBsAg Reagent Pack VITROS Calibrator Kit 26 VITROS BARB Reagent VITROS DAT Performance Verifiers VITROS NTx Range Verifier VITROS Total T4 Calibrator VITROS Total T4 Reagent Pack VITROS Progesterone Calibrator Kit VITROS Progesterone Reagent Pack Ortho Rhhr Control (human & bovine) VITROS AMYL Slides 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 TRIG Slides VITROS HPT Reagent VITROS AMON Slides VITROS Calibrator Kit 5 VITROS ASO Reagent VITROS ASO/RF Performance Verifiers VITROS Calibrator Kit 28 VITROS AST Slides VITROS PCP Reagent MTS Diluent 2 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 Immunodiagnostic Products CA 19-9 Reagent Pack VITROS FS Micro Tips VITROS Versa Tips VITROS Micro Tips ORTHO Bovine Serum Albumin, 22% Protein Concentration ORTHO Bovine Albumin Solution Polymerized VITROS COCM Reagent VITROS CRBM Slides VITROS TBIL Slides VITROS CREA Slides VITROS XT 7600 Integrated System VITROS XT 7600 Integrated System Certified VITROS XT 3400 Chemistry System VITROS AAT Reagent VITROS AAT/HPT Performance Verifiers VITROS Immunodiagnostic Products Intact PTH II Calibrators VITROS Immunodiagnostic Products Intact PTH II Reagent Pack VITROS XT GLU-Ca Slides VITROS dLDL Reagent VITROS Calibrator Kit 19 VITROS Performance Verifiers VITROS K+ Slides VITROS Anti-HBc IgM Calibrator VITROS Anti-HBc IgM Reagent Pack ORTHO Optix Reader VITROS Calibrator Kit 4 VITROS TIBC Kit ORTHO VISION Analyzer - Certified ORTHO VISION Analyzer ORTHO VISION Max Analyzer VITROS OP Reagent 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 ApoB Reagent VITROS ApoA1 Reagent VITROS Calibrator Kit 21 VITROS Calibrator Kit 22 VITROS ApoA1 Performance Verifiers VITROS ApoB Performance Verifiers VITROS Percent A1c Performance Verifiers VITROS HbA1c Reagent Kit VITROS Calibrator Kit 31 VITROS Anti-HIV 1+2 Calibrator VITROS Anti-HIV 1+2 Reagent Pack VITROS HIV Combo Calibrator VITROS HIV Combo Reagent Pack VITROS LAC Slides VITROS Anti-HBe Reagent Pack VITROS Anti-HBe Calibrators VITROS BENZ Reagent VITROS Total PSA Calibrator VITROS Total PSA Reagent Pack VITROS Calibrator Kit 99 VITROS Calibrator Kit 2 VITROS Calibrator Kit 32 VITROS Calibrator Kit 3 VITROS Anti-HBs Quantitative Controls VITROS Testosterone Range Verifier VITROS Testosterone Reagent Pack VITROS Testosterone Calibrator VITROS 350 Chemistry System VITROS 250 Chemistry System VITROS 250 Chemistry System Refurbished VITROS SALI Slides VITROS XT TBIL-ALKP Slides VITROS Anti-HCV Calibrators VITROS Anti- HCV Reagent Pack VITROS ALB-TP Slides

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2022-12-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-11-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2022-12-21
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
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
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-05-23
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2022-12-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2023-01-25
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2022-12-15
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2022-12-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-15
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2022-12-15
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
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
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2022-12-19
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2023-12-14
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2022-12-19
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	2023-01-11
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-01-11
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2023-01-09
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2022-12-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-19
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
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2023-01-11
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2022-12-15
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
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2023-02-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-21
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology	Hematology	Class 2	864.9285	2022-12-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2022-12-15
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
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2022-12-15
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2022-12-19
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2022-12-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2023-01-11
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
LDO	Enzymatic Radiochemical Assay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2022-12-19
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2024-04-02
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2024-04-02
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-04-02
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2022-12-21
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2023-01-11
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2022-12-19
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2022-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2022-12-19
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2023-01-09
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2023-01-11
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2023-01-11
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
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
KSI	Lectins And Protectins	Hematology	Class 2	864.9550	2022-12-09
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	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	2022-12-21
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2022-12-21
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2026-05-18
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2022-12-09
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-11
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2023-01-11
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-01-09
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
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-12-21
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2022-12-09
CIW	Starch-Dye Bound Polymer, Amylase	Clinical Chemistry	Class 2	862.1070	2022-12-15
QVP	Sars-Cov-2 Serology Test	Microbiology	Class 2	866.3983	2023-08-21
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2022-12-15
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2022-12-19
JID	Photometric Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2022-12-15
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2022-12-19
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2022-12-15
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	Class 2	864.9600	2022-12-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	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	2024-04-02
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2024-06-03
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2022-12-09
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2022-12-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2022-12-21
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2022-12-21
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2022-12-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-19
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2022-12-19
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2023-12-14
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2023-01-11
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-01-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2022-12-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2023-01-11
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-01-11
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
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2022-12-09
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2025-12-11
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2022-12-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2022-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2022-12-19
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2022-12-19
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2023-07-11
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2022-12-15
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-09
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2023-01-09
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2022-12-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2022-12-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2022-12-19
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2023-01-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2022-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	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
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-02-27
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2022-12-15
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2023-01-11
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2023-01-11
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2023-01-09
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2023-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

Marlene Hanna Business: Ortho-Clinical Diagnostics, Inc. Email: marlene.hanna@quidelortho.com Phone: (585) 4534041

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
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
1528450	Ortho-Clinical Diagnostics, Inc.	ATHENS, OH, 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
K022083	The Binding Site, Ltd.	HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER	2002-07-16
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0093-2023	SIEMENS HEALTHCARE DIAGNOSTICS INC	2	N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Z-0094-2023	SIEMENS HEALTHCARE DIAGNOSTICS INC	2	N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
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-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Similar Registrations

Registration Number	Establishment Name	Location
9614373	The Binding Site Group Ltd.	BIRMINGHAM, GB
3012471076	THE BINDING SITE	Kings Norton Birmingham, GB
9680746	Beckman Coulter Ireland Inc	O CALLAGHANS MILLS Clare, IE
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3012963943	Ortho Clinical Diagnostics, K.K.	Shinagawa-ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002642396. Last updated year: 2026. Please use registration number 3002642396 when referencing this establishment in official correspondence.