| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 30014613338123 | 94614 | 94614 | Triage TOX Drug Screen, 94600 Control 2 | DIF | Drug mixture control materials | 1 | Triage |
| 2 | 30014613338116 | 94613 | 94613 | Triage TOX Drug Screen, 94600 Control 1 | DIF | Drug mixture control materials | 1 | Triage |
| 3 | 30014613338109 | 94600 | 94600 | Triage TOX Drug Screen, 94600 | LAF,KHO,DIS,JXM,LFG,LDJ,JXO,DJR,DJG | Gas chromatography, methamphetamine,FLUOROMETER, FOR CLINICAL USE,Enzyme immunoa Gas chromatography, methamphetamine,FLUOROMETER, FOR CLINICAL USE,Enzyme immunoassay, barbiturate,Enzyme immunoassay, benzodiazepine,Radioimmunoassay, tricyclic antidepressant drugs,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, cocaine,Enzyme immunoassay, methadone,Enzyme immunoassay, opiates | 1 | Triage |
| 4 | 30014613338048 | 98800EU | 98800EU | Triage PLGF Test (OUS) | PZN | Placental growth factor test | Triage | |
| 5 | 30014613338031 | 98700EU | 98700EU | Triage NT-proBNP Test (OUS) | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 6 | 30014613338024 | 98600EU | 98600EU | Triage Troponin I Test (OUS) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
| 7 | 30014613338017 | 98100EU | 98100EU | Triage D-Dimer Test (OUS) | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 8 | 30014613338000 | 98100 | 98100 | Triage D-Dimer Test | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 9 | 30014613337997 | 98000XREU | 98000XREU | Triage BNP Test (OUS) | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 10 | 30014613337980 | 98000XR | 98000XR | Triage BNP Test | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 11 | 30014613337973 | 97500EU | 97500EU | Triage Cardio2 Panel | NBC,MMI | TEST,NATRIURETIC PEPTIDE,IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
| 12 | 30014613337966 | 97400EU | 97400EU | Triage Cardio3 Panel | MMI,JHX,NBC | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,TEST IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 13 | 30014613337959 | 97300EU | 97300EU | Triage Profiler SOB Panel (OUS) | DDR,MMI,JHX,NBC,DAP | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUO MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,TEST,NATRIURETIC PEPTIDE,FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 14 | 30014613337942 | 97022HS | 97022HS | Triage Cardiac Panel (CK/TnI) | MMI,JHX | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Triage |
| 15 | 30014613337935 | 97021HS | 97021HS | Triage Cardiac Panel (TnI) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
| 16 | 30014613337928 | 97000HSEU | 97000HSEU | Triage Cardiac Panel (OUS) | DOR,MMI,JHX | RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.,IMMUNOASSAY METH RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Triage |
| 17 | 30014613337911 | 97000HS | 97000HS | Triage Cardiac Panel | MMI,JHX,DDR | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOG IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
| 18 | 30014613337904 | 94400EU | 94400EU | Triage TOX Drug Screen (OUS) | LAF,LDP,DKZ,DJG,LCM,LDJ,DIS,JXO,MLK,JXM,DJR | Gas chromatography, methamphetamine,COLORIMETRY, ACETAMINOPHEN,Enzyme immunoassa Gas chromatography, methamphetamine,COLORIMETRY, ACETAMINOPHEN,Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, methadone | 2 | Triage |
| 19 | 30014613337898 | 94404 | 94404 | Triage TOX Drug Screen (7 Panel) | LAF,DKZ,DJG,DIS,JXO,JXM,LDJ | Gas chromatography, methamphetamine,Enzyme immunoassay, amphetamine,Enzyme immun Gas chromatography, methamphetamine,Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, cannabinoids | 2 | Triage |
| 20 | 30014613337881 | 94402 | 94402 | Triage TOX Drug Screen (9 Panel) | DKZ,DJG,LAF,LCM,MLK,JXO,LDJ,DIS,JXM | Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Gas chromatography, Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Gas chromatography, methamphetamine,Enzyme immunoassay, phencyclidine,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, cocaine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, benzodiazepine | 2 | Triage |
| 21 | 30014613337874 | 94401 | 94401 | Triage TOX Drug Screen (10 Panel) | MLK,LCM,DKZ,DJR,LAF,DIS,LDJ,JXM,DJG,JXO | Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, p Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, amphetamine,Enzyme immunoassay, methadone,Gas chromatography, methamphetamine,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, opiates,Enzyme immunoassay, cocaine | 2 | Triage |
| 22 | 30014613337867 | 94400 | 94400 | Triage TOX Drug Screen | LDP,MLK,DKZ,LAF,JXM,LCM,LDJ,DIS,JXO,DJR,DJG | COLORIMETRY, ACETAMINOPHEN,Thin layer chroomatography, tricyclic antidepressant COLORIMETRY, ACETAMINOPHEN,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, amphetamine,Gas chromatography, methamphetamine,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Enzyme immunoassay, methadone,Enzyme immunoassay, opiates | 2 | Triage |
| 23 | 30014613337720 | 98202 | 98202 | Triage BNP Calibrators | JIT | Calibrator, secondary | 2 | Triage |
| 24 | 30014613337713 | 98201 | 98201 | Triage BNP QC Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 25 | 30014613337706 | 98200 | 98200 | Triage BNP Reagents | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
| 26 | 30014613337157 | 55070 | 55070 | Triage MeterPro, North America | MMI,JHX,DDR,KHO | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOG IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,FLUOROMETER, FOR CLINICAL USE | 1 | Triage |
| 27 | 30014613337140 | 94414 | 94414 | Quidel Triage TOX Drug Screen Control 2 | DIF | Drug mixture control materials | 1 | Triage |
| 28 | 30014613337133 | 94413 | 94413 | Quidel Triage TOX Drug Screen Control 1 | DIF | Drug mixture control materials | 1 | Triage |
| 29 | 30014613337126 | 88755 | 88755 | Quidel Triage Total 5 Calibration Verification | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 30 | 30014613337119 | 88754 | 88754 | Quidel Triage Total 5 Control 2 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 31 | 30014613337102 | 88753 | 88753 | Quidel Triage Total 5 Control 1 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 32 | 30014613337096 | 88734 | 88734 | Quidel Triage Total 3 Control 2 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 33 | 30014613337089 | 88733 | 88733 | Quidel Triage Total 3 Control 1 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
| 34 | 30014613337072 | 98814EU | 98814EU | Triage PLGF Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 35 | 30014613337065 | 98813EU | 98813EU | Triage PLGF Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 36 | 30014613337058 | 98714EU | 98714EU | Triage NT-proBNP Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 37 | 30014613337041 | 98713EU | 98713EU | Triage NT-proBNP Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 38 | 30014613337034 | 98015XR | 98015XR | Quidel Triage® BNP Calibration Verification | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 39 | 30014613337027 | 98014XR | 98014XR | Quidel Triage® BNP Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| 40 | 30014613337010 | 98013XR | 98013XR | Triage BNP Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04897078440106 | THETIS220 | 10103 | Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. This device is a fluorescent immunoassay system intended to be used with Test Kits manufactured by Sanwa BioTech. This device is for professional use in a near-patient setting or laboratory use. | Thetis Fluorescent Immunoassay System | SANWA BIOTECH LIMITED |
| 2 | 04897078440052 | ARIEL220 | 10102 | Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable r Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. This device is a fluorescent immunoassay system intended to be used with Test Kits manufactured by Sanwa BioTech. This device is for professional use in a near-patient setting or laboratory use. | Ariel Fluorescent Immunoassay System | SANWA BIOTECH LIMITED |
| 3 | 04897078440045 | DX320 | 10101 | ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platfo ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. ALiA FIA Analyser is intended to be used alongside with IVD and other test kits developed by Sanwa BioTech. ALiA is to be used for the detection of fluorescent signals in immunoassays for the identification of biomarkers in near-patient testing or for laboratory use. | ALiA FIA Analyser | SANWA BIOTECH LIMITED |
| 4 | 04560189284623 | AIA-2000 LA | N/A | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 LA | TOSOH CORPORATION | |
| 5 | 04560189284616 | AIA-2000 ST | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST | TOSOH CORPORATION | ||
| 6 | 04560189284012 | N/A | 19tray Sorter | TOSOH CORPORATION | ||
| 7 | 04560189284005 | N/A | 9tray Sorter | TOSOH CORPORATION | ||
| 8 | 04560189283992 | AIA-900 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | TOSOH CORPORATION | ||
| 9 | 04560189282896 | AIA-360 | AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 | TOSOH CORPORATION | ||
| 10 | 04560189211681 | N/A | AIA-PACK CK-MB Sample Diluting Solution | TOSOH CORPORATION | ||
| 11 | 04560189211674 | N/A | AIA-PACK CK-MB Calibrator Set | TOSOH CORPORATION | ||
| 12 | 04560189211049 | N/A | ST AIA-PACK cTnI 2 Sample Dilting Solution | TOSOH CORPORATION | ||
| 13 | 04560189211025 | N/A | ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
| 14 | 04560189211018 | N/A | ST AIA-PACK Myoglobin CALIBRATOR SET | TOSOH CORPORATION | ||
| 15 | 04015630942695 | 07398000160 | 07398000160 | Elecsys Troponin T Gen 5 STAT | ROCHE DIAGNOSTICS GMBH | |
| 16 | 04015630940059 | 07027583190 | 07027583190 | Elecsys Myoglobin | ROCHE DIAGNOSTICS GMBH | |
| 17 | 04015630939541 | 07394675190 | 07394675190 | CalSet Myoglobin | ROCHE DIAGNOSTICS GMBH | |
| 18 | 04015630939381 | 5094798160 | 5094798160 | Elecsys Troponin I STAT Immunoassay | ROCHE DIAGNOSTICS GMBH | |
| 19 | 04015630939374 | 5094810160 | 5094810160 | Elecsys Troponin I Immunoassay | ROCHE DIAGNOSTICS GMBH | |
| 20 | 04015630939077 | 11820788160 | 11820788160 | Elecsys Myoglobin STAT Immunoassay | ROCHE DIAGNOSTICS GMBH | |
| 21 | 04015630939060 | 12178214160 | 12178214160 | Elecsys Myoglobin Immunoassay | ROCHE DIAGNOSTICS GMBH | |
| 22 | 04015630928644 | 5950759190 | 5950759190 | Tinaquant Myoglobin Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 23 | 04015630922475 | 4856643190 | 4856643190 | Elecsys Troponin T STAT CalSet | ROCHE DIAGNOSTICS GMBH | |
| 24 | 04015630922468 | 4856627190 | 4856627190 | Elecsys Troponin T CalSet | ROCHE DIAGNOSTICS GMBH | |
| 25 | 04015630921621 | 4660307190 | 4660307190 | Elecsys Troponin T STAT Assay | ROCHE DIAGNOSTICS GMBH | |
| 26 | 04015630921294 | 4580010190 | 4580010190 | Tinaquant Myoglobin Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 27 | 04015630921270 | 4579976190 | 4579976190 | Myoglobin Gen2 Tinaquant Myoglobin Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 28 | 04015630920938 | 4491815190 | 4491815190 | Elecsys Troponin T | ROCHE DIAGNOSTICS GMBH | |
| 29 | 04015630914449 | 12178222122 | 12178222122 | Elecsys Myoglobin CalSet | ROCHE DIAGNOSTICS GMBH | |
| 30 | 04015630911707 | 11820893122 | 11820893122 | Elecsys Myoglobin STAT CalSet | ROCHE DIAGNOSTICS GMBH | |
| 31 | 04015630901234 | 11937553193 | 11937553193 | Roche CARDIAC Control Troponin T | ROCHE DIAGNOSTICS GMBH | |
| 32 | 04015630002481 | 11621947196 | 11621947196 | Roche CARDIAC TROP T Sensitive | ROCHE DIAGNOSTICS GMBH | |
| 33 | 03573026229115 | 30448-01 | VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma. | VIDAS® TROPONIN I Ultra | BIOMERIEUX SA | |
| 34 | 03573026161613 | 30421-01 | The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS ins The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma. | VIDAS® CK-MB | BIOMERIEUX SA | |
| 35 | 00899722002795 | 97022HS | 97022HS | Alere Triage® Cardiac Panel, CK-MB and TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
| 36 | 00899722002795 | 97022HS | 97022HS | Alere Triage® Cardiac Panel, CK-MB and TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
| 37 | 00899722002788 | 97021HS | 97021HS | Alere Triage® Cardiac Panel, TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
| 38 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
| 39 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
| 40 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
| 41 | 00899722002719 | 97000HSEU | 97000HSEU | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
| 42 | 00899722002719 | 97000HSEU | 97000HSEU | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
| 43 | 00899722002719 | 97000HSEU | 97000HSEU | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
| 44 | 00895160002496 | TF3154 | TF3154 | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma | Fluoro-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION |
| 45 | 00895160002496 | TF3154 | TF3154 | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma | Fluoro-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION |
| 46 | 00895160002458 | CD402P | CD402P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma | Nano-CheckTM 4 in 1 Test | NANO-DITECH CORPORATION |
| 47 | 00895160002458 | CD402P | CD402P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma | Nano-CheckTM 4 in 1 Test | NANO-DITECH CORPORATION |
| 48 | 00895160002137 | CD302P | CD302P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION |
| 49 | 00895160002137 | CD302P | CD302P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION |
| 50 | 00895160002120 | CD202P | CD202P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglob In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma | Nano-CheckTM AMI 2 in 1 | NANO-DITECH CORPORATION |