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 | 00695684774103 | ILM-0001A | Triglycerides test strip | JGY | Colorimetric Method, Triglycerides | 1 | AimStrip Tandem Total Triglycerides Test Strips | |
14 | 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 | |
15 | 08809115905697 | IGM-1003A | Blood Glucose Test strips Refill kit | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip Refill kit | |
16 | 00695684773106 | ILM-0001A | Total Cholestesol test strip | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | AimStrip Tandem Total Cholesterol Test Strips | |
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 | 17311091107234 | 110723 | 110723 | HemoCue Glucose 201 Microcuvettes 2x25 single | HemoCue® Glucose 201 Microcuvettes | HEMOCUE AB |
2 | 17311091107067 | 110706 | 110706 | HemoCue Glucose 201 Microcuvettes 4x25 vial | HemoCue® Glucose 201 Microcuvettes | HEMOCUE AB |
3 | 17311091107050 | 110705 | 110705 | HemoCue Glucose 201 Microcuvettes 4x25 single | HemoCue® Glucose 201 Microcuvettes | HEMOCUE AB |
4 | 15430001412137 | 1 | In vitro transcript of Mycoplasma genitalium 23S RNA | Mycoplama genitalium IVT Wild type control | DIAGENODE | |
5 | 15430001412120 | 1 | PRD-06113 | In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation | Mycoplasma genitamium macrolide resistance IVT A 2059G control | DIAGENODE |
6 | 15430001412113 | 1 | In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation | Mycoplasma genitalium macrolide resistance IVT A2059C Control | DIAGENODE | |
7 | 15430001412106 | 1 | PRD-06111 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058T mutation | Mycoplasma genitalium macrolide resistance IVT A2058T Controls | DIAGENODE |
8 | 15430001412090 | 1 | PRD-06110 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation | Mycoplasma genitalium macrolide resistance IVT A2058G Control | DIAGENODE |
9 | 15430001412083 | 1 | PRD-06109 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058C mutation | Mycoplasma genitalium Macrolide Resistance IVT A2058C Control | DIAGENODE |
10 | 15420045509382 | CLASS I CONTROL - C. GLABRATA | PRD-04522 | Aptima | HOLOGIC, INC. | |
11 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | aptima | HOLOGIC, INC. | |
12 | 15420045509368 | CLASS I CONTROL - G. VAGINALIS | PRD-04520 | Aptima | HOLOGIC, INC. | |
13 | 15420045509351 | CLASS I CONTROL - L. CRISPATUS | PRD-04519 | Aptima | HOLOGIC, INC. | |
14 | 15099590750954 | 98201 | 98201 | The Access BNP QC Controls are intended for monitoring the performance of the Ac The Access BNP QC Controls are intended for monitoring the performance of the Access BNP test using the Beckman Coulter Access Family of Immunoassay Systems. | Access BNP QC | BECKMAN COULTER, INC. |
15 | 15099590677398 | B83877 | B83877 | The Access Ostase QC is intended for monitoring system performance of the Access The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | Access Ostase QC | BECKMAN COULTER, INC. |
16 | 15099590233501 | 472500 | 472500 | Glucose Reagent (Glucose Oxidase) | Synchron | BECKMAN COULTER, INC. |
17 | 15099590232290 | 37309 | 37309 | The Access Ostase QC is intended for monitoring system performance of the Access The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | Access Ostase QC | BECKMAN COULTER, INC. |
18 | 15099590232108 | 650038 | 650038 | Vigil HbA1c Controls Levels 1 & 2 | Vigil | BECKMAN COULTER, INC. |
19 | 15099590229108 | 387999 | 387999 | The Access Intrinsic Factor Ab QC is intended for monitoring system performance The Access Intrinsic Factor Ab QC is intended for monitoring system performance of the Access Intrinsic Factor Ab assay. | Access Intrinsic Factor Ab QC | BECKMAN COULTER, INC. |
20 | 15099590228705 | 667710 | 667710 | Ultimate -D Bilirubin Control Level 1 | Ultimate | BECKMAN COULTER, INC. |
21 | 15099590223038 | 667720 | 667720 | Ultimate -D Bilirubin Control Level 2 | Ultimate | BECKMAN COULTER, INC. |
22 | 15099590223021 | 667730 | 667730 | Ultimate -D Bilirubin Control Level 3 | Ultimate | BECKMAN COULTER, INC. |
23 | 15099590223014 | 667740 | 667740 | Ultimate -D Bilirubin Control Level 4 | Ultimate | BECKMAN COULTER, INC. |
24 | 15099590210717 | B11057 | B11057 | The Access sTfR QC2 and QC3 is intended for monitoring system performance of the The Access sTfR QC2 and QC3 is intended for monitoring system performance of the Access sTfR assay. | Access sTfR QC2 and QC3 | BECKMAN COULTER, INC. |
25 | 15099590210700 | B11056 | B11056 | The Access sTfR QC1 is intended for monitoring system performance of the Access The Access sTfR QC1 is intended for monitoring system performance of the Access sTfR assay. | Access sTfR QC1 | BECKMAN COULTER, INC. |
26 | 15099590204051 | A48619 | A48619 | The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay. | Access SHBG QC | BECKMAN COULTER, INC. |
27 | 15099590203061 | A36100 | A36100 | The Access Inhibin A QC is intended for monitoring system performance of the Acc The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay. | Access Inhibin A QC | BECKMAN COULTER, INC. |
28 | 14987481164496 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | uTASWako DCP Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
29 | 14987481164489 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | uTASWako DCP Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
30 | 14987481164458 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
31 | 14987481164441 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
32 | 14712558769416 | eB-S01 | eBchek | VISGENEER, INC. | ||
33 | 14712558769409 | eB-S01 | eBchek | VISGENEER, INC. | ||
34 | 10888277675698 | MPH6560 | MPH6560 | CONTROL, HARMONY HI LO | Medline | MEDLINE INDUSTRIES, INC. |
35 | 10888277675681 | MPH6550 | MPH6550 | STRIP,TEST,GLUCOSE,HARMONY | Medline | MEDLINE INDUSTRIES, INC. |
36 | 10888277409187 | MPH4560 | MPH4560 | CONTROL,EVENCARE PRO, HI LO | Medline | MEDLINE INDUSTRIES, INC. |
37 | 10888277409170 | MPH4550 | MPH4550 | STRIP,GLUCOSE,EVENCARE PRO | Medline | MEDLINE INDUSTRIES, INC. |
38 | 10888277409163 | MPH4540 | MPH4540 | METER,GLUCOSE,EVENCARE PROVIEW,PROF.USE | Medline | MEDLINE INDUSTRIES, INC. |
39 | 10888277365940 | MPH3550FL | MPH3550FL | STRIP, GLUCOSE, FOIL, G3, PROF.USE ONLY | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. |
40 | 10888277177505 | MPHCABLE | MPHCABLE | CABLE, GLUCOSE, EVENCARE | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. |
41 | 10885502002199 | IGM-0035 | G8-203S50 | Easygluco® Plus Test Strips | U.S. DIAGNOSTICS INC. | |
42 | 10885502002199 | IGM-0035 | G8-203S50 | Easygluco® Plus Test Strips | U.S. DIAGNOSTICS INC. | |
43 | 10885502002045 | IGM-0009 | IGM-G3-203 | Control™ Test Strips | U.S. DIAGNOSTICS INC. | |
44 | 10885502002045 | IGM-0009 | IGM-G3-203 | Control™ Test Strips | U.S. DIAGNOSTICS INC. | |
45 | 10885502002038 | IGM-0008 | IGM-G2-203 | EasyGluco™G2 Test Strips | U.S. DIAGNOSTICS INC. | |
46 | 10885502002038 | IGM-0008 | IGM-G2-203 | EasyGluco™G2 Test Strips | U.S. DIAGNOSTICS INC. | |
47 | 10885502002007 | IGM-0024 | G5-203S50 | INFINITY™ Test Strips | U.S. DIAGNOSTICS INC. | |
48 | 10885502002007 | IGM-0024 | G5-203S50 | INFINITY™ Test Strips | U.S. DIAGNOSTICS INC. | |
49 | 10884389831205 | MPH3550 | MPH3550 | STRIP,GLUCOSE,EVENCARE G3,PROF.USE ONLY | Medline | MEDLINE INDUSTRIES, INC. |
50 | 10884389831199 | MPH3540 | MPH3540 | METER,GLUCOSE,EVENCARE G3,PROF.USE ONLY | Medline | MEDLINE INDUSTRIES, INC. |