No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00695684775506 | ILM-0001A | AimStrip Tandem blood glucose test strips | CGA | Glucose Oxidase, Glucose | 2 | AimStrip Tandem blood glucose test strips | |
2 | 00695684773120 | ILM-0001A | Lipid measuring meter and Total Cholesterol test strip control solution level 1,2 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AimStrip Tandem Total Cholesterol Control Solution | |
3 | 00695684773014 | ILM-0001A | Lipid and Glucose Measuring System | CGA,JJX,CHH,JGY | Glucose Oxidase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassa Glucose Oxidase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),Enzymatic Esterase--Oxidase, Cholesterol,Colorimetric Method, Triglycerides | 1 | AimStrip Tandem Lipid Profile and glucose measuring system | |
4 | 08809115905802 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'care Lite Smart Glucose Meter | ||
5 | 08809115904645 | OI-01SA-SH | FBE00625 | 1 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
6 | 08809115904621 | OI-01SA-SH | FBE00608 | 2 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
7 | 08809115904614 | OI-01SA-SH | FBE00626 | 4 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
8 | 08809115904607 | OI-01SA-SH | FBE00627 | 5 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
9 | 08809115904591 | OI-01SA-SH | FBE00641 | 25 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
10 | 00793150629794 | IGM-1003A | INFCN003L | Glucose Control Solution | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Oh’Care Lite Glucose Control Solution |
11 | 00793150629770 | IGM-1003A | INFM003L | Blood Glucose Monitoring System for Self-Testing | NBW,LFR | System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | 2 | Oh’Care Lite Blood Glucose Monitoring System for Self-Testing |
12 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | JJX,NBW,LFR | Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | 1 | Oh’Care Lite Blood Glucose Monitoring System Kit | |
13 | 08809115906519 | IGM-1003F | blood glucose meter and test strip control solution level 1 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Oh'Care Lite Smart Glucose control solution-Level 1 | |
14 | 08809115905697 | IGM-1003A | Blood Glucose Test strips Refill kit | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip Refill kit | |
15 | 00695684773106 | ILM-0001A | Total Cholestesol test strip | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | AimStrip Tandem Total Cholesterol Test Strips | |
16 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | JJX,NBW,CGA | Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Element™ Meter | ||
17 | 08809115906540 | IGM-1003F | blood glucose test strip | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'Care Lite Smart Glucose Test Strip | |
18 | 08809115905406 | ILM-0001A | CHH,JGY | Enzymatic Esterase--Oxidase, Cholesterol,Colorimetric Method, Triglycerides | 1 | CURO L5 Meter | ||
19 | 00793150629787 | IGM-1003A | INFS003L | Blood Glucose Test strips | NBW,LFR | System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | 2 | Oh’Care Lite Blood Glucose Test strips |
20 | 08809115908957 | IGM-0021B | Blood Glucose Monitoring System | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Element™Plus Test Strips | ||
21 | 08809115908438 | IGM-0021B | Blood Glucose Monitoring System | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Element™ Test Strips | ||
22 | 08809115905710 | IGM-1003A | Blood Glucose Test strips | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip | |
23 | 08809115905444 | ILM-0001A | JGY | Colorimetric Method, Triglycerides | 1 | CURO L5 TG test strip | ||
24 | 00695684775124 | ILM-0001A | blood glucose meter and test strip control solution-level 1,2,3 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AimStrip Tandem Glucose control solution | |
25 | 08809115905413 | ILM-0001A | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | CURO L5 TC test strip | ||
26 | 08809115905369 | IGM-1003A | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip(25T) | ||
27 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | CGA,NBW,JJX | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter,Single (S Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Element™Plus Meter | |
28 | 08809115905796 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'care Lite Smart Glucose Test Strip | ||
29 | 08809115905727 | IGM-1003A | blood glucose monitoring system for self-testing meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose meter | |
30 | 08809115905703 | IGM-1003A | blood glucose monitoring system for self-testing starter kit | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose monitoring system starter kit | |
31 | 08809115905376 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Pro Glucose meter | ||
32 | 08809115904263 | OI-01SA-SH | FBE00656 | 1 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
33 | 08809115904256 | OI-01SA-SH | FBE00657 | 2 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
34 | 08809115904249 | OI-01SA-SH | FBE00658 | 4 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
35 | 08809115904232 | OI-01SA-SH | FBE00659 | 5 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
36 | 08809115904225 | OI-01SA-SH | FBE00660 | 25 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
37 | 08809115905352 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Pro Glucose monitoring system starter kit | ||
38 | 00695684774127 | ILM-0001A | Lipid measuring meter and Triglycerides test strip control solution level 1,2 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AimStrip Tandem Total Triglycerides Control Solution | |
39 | 08809115906557 | IGM-1003F | blood glucose monitoring system for self-testing | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'Care Lite Smart Glucose monitoring system | |
40 | 08809115906526 | IGM-1003F | blood glucose meter and test strip control solution-Level 2 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Oh'Care Lite Smart Glucose control solution-Level 2 | |
41 | 08809115904119 | ILM-0001A | INFSG001EF | Glucose test strip(25T) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CURO L5 Glucose test strip |
42 | 08809115906533 | IGM-1003F | blood glucose meter and test strip control solution-level 3 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Oh'Care Lite Smart Glucose control solution-Level 3 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04571226470831 | 14-531 | 14-531 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
2 | 00899722002344 | 99021 | 99021 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
3 | 00899722002337 | 99020 | 99020 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
4 | 00893038002845 | 88773 | 88773 | Alere Cholestech LDX® Multianalyte Controls | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
5 | 00893038002654 | 10-991 | 10-991 | Alere Cholestech LDX® Lipid Profile●GLU | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
6 | 00893038002630 | 10-989 | 10-989 | Alere Cholestech LDX® Lipid Profile | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
7 | 00893038002210 | 88769 | 88769 | Alere Cholestech LDX® Multianalyte Controls (2 X 2ml) | Alere Cholestech LDX® | ALERE SAN DIEGO, INC. |
8 | EABA40000301 | 400-0030 | 400-0030 | The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Lipid Panel Plus | ABAXIS, INC. |
9 | EABA40000251 | 400-0025 | 400-0025 | The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry an The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Lipid Panel | ABAXIS, INC. |
10 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | CURO L5 Total Cholesterol Strips | KPI HEALTHCARE, INC. | |
11 | 00860394001225 | CURO L5 CURO L5 | CURO L5 Cholesterol and Glucose measuring system | CURO L5 | KPI HEALTHCARE, INC. | |
12 | 00850006113064 | Curo L5 | CURO L5 Glucose Strip | Curo L5 | KPI HEALTHCARE, INC. | |
13 | 00695684774103 | ILM-0001A | Triglycerides test strip | AimStrip Tandem Total Triglycerides Test Strips | OSANG HEALTHCARE CO., LTD. | |
14 | 00695684773014 | ILM-0001A | Lipid and Glucose Measuring System | AimStrip Tandem Lipid Profile and glucose measuring system | OSANG HEALTHCARE CO., LTD. | |
15 | 00381934750019 | 4750 | 4750 | The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen. | CardioChek Plus Home Self-Test Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. |
16 | 00381934722016 | 4722 | 4722 | CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test analyzer. | CardioChek Plus Home Lipid Panel Self-Test Strip 2ct | POLYMER TECHNOLOGY SYSTEMS, INC. |
17 | 00381934721019 | 4721 | 4721 | CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitr CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitro diagnostic devices used to measure glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer. | CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct | POLYMER TECHNOLOGY SYSTEMS, INC. |
18 | 00381934720012 | 4720 | 4720 | The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen. | CardioChek Plus Home Self-Test Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. |
19 | 00381932729017 | 2729 | 2729 | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic d CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic devices used to monitor glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus analyzer. | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) | POLYMER TECHNOLOGY SYSTEMS, INC. |
20 | 00381932702010 | 2702 | 2702 | The CardioChek® Plus professional analyzer is intended for in vitro diagnostic u The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. | CardioChek® Plus Professional Analyzer, Refurbished | POLYMER TECHNOLOGY SYSTEMS, INC. |
21 | 00381932701013 | 2701 | 2701 | The CardioChek® Plus professional analyzer is intended for in vitro diagnostic u The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. | CardioChek® Plus Professional Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. |
22 | 00381932700016 | 2700 | 2700 | The CardioChek® Plus professional analyzer is intended for in vitro diagnostic u The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. | CardioChek® Plus Professional Analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. |
23 | 00381932478014 | 2478 | 2478 | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic d CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic devices used to monitor glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus analyzer. | CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) | POLYMER TECHNOLOGY SYSTEMS, INC. |
24 | 00381932470018 | 2470 | 2470 | PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to moni PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to monitor total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA or Plus analyzer. | PTS Panels® Lipid Panel Test Strips (10-ct) | POLYMER TECHNOLOGY SYSTEMS, INC. |
25 | 00381932400015 | 2400 | 2400 | PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monitor glucose; HDL cholesterol; and triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer. | PTS Panels® Metabolic ChemistryTest Strips | POLYMER TECHNOLOGY SYSTEMS, INC. |
26 | 00381931789012 | 1789 | 1789 | PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to mo PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. | PTS Panels® Triglycerides Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. |
27 | 00381931782013 | 1782 | 1782 | The CardioChek® analyzer is intended for in vitro diagnostic use to test whole b The CardioChek® analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. | CardioChek® Analyzer; Refurbished | POLYMER TECHNOLOGY SYSTEMS, INC. |
28 | 00381931757011 | 1757 | 1757 | The CardioChek® PA professional analyzer is intended for in vitro diagnostic use The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. | CardioChek® PA Professional Analyzer, Refurbished | POLYMER TECHNOLOGY SYSTEMS, INC. |
29 | 00381931716018 | 1716 | 1716 | PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to mo PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. | PTS Panels® Triglycerides Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. |
30 | 00381931710016 | 1710 | 1710 | PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to moni PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to monitor total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA or Plus analyzer. | PTS Panels® Lipid Panel Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. |
31 | 00381931709010 | 1709 | 1709 | The CardioChek® analyzer is intended for in vitro diagnostic use to test whole b The CardioChek® analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. | CardioChek® analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. |
32 | 00381931708013 | 1708 | 1708 | The CardioChek® PA professional analyzer is intended for in vitro diagnostic use The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. | CardioChek® PA analyzer | POLYMER TECHNOLOGY SYSTEMS, INC. |
33 | 00381930860019 | 860 | 860 | ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms. | ChekMate™ Strips | POLYMER TECHNOLOGY SYSTEMS, INC. |
34 | 00304040040539 | 5700534 | 5700534 | CardioChek Plus Analyzer Starter Pack | CardioChek | HENRY SCHEIN, INC. |
35 | 00304040037713 | 5700411 | 5700411 | CardioChek Plus Analyzer | CardioChek | HENRY SCHEIN, INC. |
36 | 10763924550507 | MD550 | Lipid and Glucose Measuring System | LipidPlus® Meter | JANT PHARMACAL CORPORATION | |
37 | 10304040037741 | 5700414 | 5700414 | CardioChek Lipid Panel Test | CardioChek | HENRY SCHEIN, INC. |
38 | 10304040037734 | 5700412 | 5700412 | CardioChek 15Lipid/15Glucose | CardioChek | HENRY SCHEIN, INC. |
39 | 08809319396512 | 99LS10-2 | CURO L7 Lipid Test Strip - Lipid Profile | SD BIOSENSOR, INC. | ||
40 | 08809319396161 | 99LA10G-2 | CURO L7 Analyzer | SD BIOSENSOR, INC. | ||
41 | 08809115905444 | ILM-0001A | CURO L5 TG test strip | OSANG HEALTHCARE CO., LTD. | ||
42 | 08809115905406 | ILM-0001A | CURO L5 Meter | OSANG HEALTHCARE CO., LTD. |