Quidel Cardiovascular Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3013982035

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
3013982035
FEI Number
3013982035
Entity Name
Quidel Cardiovascular Inc.
City/State/Country
San Diego, CA, US
Establishment Address
9975 Summers Ridge Road, --, San Diego, CA 92121, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
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
N/A
PMA Number
N/A

All Registered Proprietary Names

Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage(R) Cardiac Panel Quidel Triage(R) Profiler SOB Panel Quidel Triage(R) Cardio3 Panel Quidel Triage(R) Cardio3 Panel Quidel Triage(R) Cardio2 Panel Quidel Triage(R) Profiler SOB Panel Quidel Triage NT-proBNP Test Quidel Triage(R) BNP Test Quidel Triage(R) BNP Calibration Verification Quidel Triage(R) PLGF Test Quidel Triage(R) Profiler SOB Panel Quidel Triage(R) D-Dimer Test Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage TOX Drug Screen, 94600 Control 2 Quidel Triage TOX Drug Screen, 94600 Control 1 Quidel Triage(R) Total 5 Calibration Verification Quidel Triage(R) Total 5 Control 1 Quidel Triage(R) Total 5 Control 2 Quidel Triage(R) BNP Control 1 Quidel Triage(R) BNP Control 2 Quidel Triage(R) D-Dimer Test Quidel Triage(R) Cardiac Panel Quidel Triage(R) Cardio2 Panel Quidel Triage(R) Cardio3 Panel Quidel Triage(R) Profiler SOB Panel Quidel Triage(R) Troponin I Test Quidel TriageTrue(R) High Sensitivity Troponin I Test Quidel Triage(R) MeterPro Quidel Triage(R) Total 3 Control 2 Quidel Triage(R) Total 3 Control 1 Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage(R) TOX Drug Screen, 94600 Control 2 Quidel Triage(R) TOX Drug Screen, 94600 Control 1 Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage(R) PLGF Control 2 Quidel Triage(R) NT-proBNP Control 1 Quidel Triage(R) NT-proBNP Control 2 Quidel Triage(R) PLGF Control 1 Quidel Triage(R) Profiler SOB Panel Quidel Triage(R) Cardiac Panel Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage(R) TOX Drug Screen, 94600 Quidel Triage(R) TOX Drug Screen, 94600

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2017-10-17
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2017-10-17
JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2017-10-17
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2017-10-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-10-17
PZN Placental Growth Factor Test Unknown Class N N/A 2017-11-02
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2017-10-17
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2022-10-14
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2019-06-24
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2017-10-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-10-17
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2017-10-17
GHH Fibrin Split Products Hematology Class 2 864.7320 2017-10-17
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2017-10-17
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2017-10-17
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2017-10-17
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2017-10-17
JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2017-10-17
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2017-10-17
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2017-10-17
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2022-10-14
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2017-10-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-10-17
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2017-10-17
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2017-10-17
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2017-11-15
JXO Enzyme Immunoassay, Cocaine Clinical Toxicology Class 2 862.3250 2017-10-17
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2017-10-17

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
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
K833577 Syva Co. MODIF. OF EMIT URINE BARBITURATE 1984-01-26
K143535 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Secobarbital- Methadone 2015-01-13
K050024 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS 2005-11-17
K920417 Instrumentation Laboratory CO IL TEST BARBITURATE, 35289 1992-04-24
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-2787-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
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-0030-2012 Tcoag Us, Incorporated 2
Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888, Web: www.trinitybiotech.com Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013982035. Last updated year: 2026. Please use registration number 3013982035 when referencing this establishment in official correspondence.
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