| 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 | 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 | ||
| 18 | 08809115906540 | IGM-1003F | blood glucose test strip | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'Care Lite Smart Glucose Test Strip | |
| 19 | 08809115905406 | ILM-0001A | CHH,JGY | Enzymatic Esterase--Oxidase, Cholesterol,Colorimetric Method, Triglycerides | 1 | CURO L5 Meter | ||
| 20 | 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 |
| 21 | 08809115908957 | IGM-0021B | Blood Glucose Monitoring System | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Element™Plus Test Strips | ||
| 22 | 08809115908438 | IGM-0021B | Blood Glucose Monitoring System | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Element™ Test Strips | ||
| 23 | 08809115905710 | IGM-1003A | Blood Glucose Test strips | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip | |
| 24 | 08809115905444 | ILM-0001A | JGY | Colorimetric Method, Triglycerides | 1 | CURO L5 TG test strip | ||
| 25 | 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 | |
| 26 | 08809115905413 | ILM-0001A | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | CURO L5 TC test strip | ||
| 27 | 08809115905369 | IGM-1003A | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip(25T) | ||
| 28 | 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 | |
| 29 | 08809115905796 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'care Lite Smart Glucose Test Strip | ||
| 30 | 08809115905727 | IGM-1003A | blood glucose monitoring system for self-testing meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose meter | |
| 31 | 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 | |
| 32 | 08809115905376 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Pro Glucose meter | ||
| 33 | 08809115904263 | OI-01SA-SH | FBE00656 | 1 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
| 34 | 08809115904256 | OI-01SA-SH | FBE00657 | 2 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
| 35 | 08809115904249 | OI-01SA-SH | FBE00658 | 4 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
| 36 | 08809115904232 | OI-01SA-SH | FBE00659 | 5 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
| 37 | 08809115904225 | OI-01SA-SH | FBE00660 | 25 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
| 38 | 08809115905352 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Pro Glucose monitoring system starter kit | ||
| 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 | 04260236851159 | 3S-01-160037 | 3S-01-160037 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | PRECICHEK AutoCode vial packed test strip | HMD BIOMEDICAL INC. |
| 2 | 04260236851142 | 3L-10-16003B | 3L-10-16003B | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 3 | 04260236851111 | 3L-10-16003H | 3L-10-16003H | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 4 | 04260236851067 | 3L-10-16003G | 3L-10-16003G | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 5 | 04260236851050 | 3K-01-16003X | 3K-01-16003X | PRECICHEK AC300 Blood Glucose Monitoring System. | PRECICHEK AC300 | HMD BIOMEDICAL INC. |
| 6 | 04260236850916 | 3S-01-16003F | 3S-01-16003F | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | PRECICHEK AutoCode vial packed test strip | HMD BIOMEDICAL INC. |
| 7 | 04260236850664 | 3L-10-16003D | 3L-10-16003D | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 8 | 04260236850619 | 3K-01-16003A | 3K-01-16003A | PRECICHEK AutoCode AC302 Blood Glucose Monitoring System. | PRECICHEK AutoCode AC302 | HMD BIOMEDICAL INC. |
| 9 | 04260236850411 | 3S-01-160032 | 3S-01-160032 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip | PRECICHEK AutoCode vial packed test Strip | HMD BIOMEDICAL INC. |
| 10 | 04260236850329 | 3L-10-160031 | 3L-10-160031 | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 11 | 04250317546517 | 0318 | 0318 | MassCheck® Methylmalonic Acid Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 12 | 04250317546500 | 0317 | 0317 | MassCheck® Methylmalonic Acid Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 13 | 04250317546494 | 0315 | 0315 | MassCheck® Methylmalonic Acid Plasma Control Level II | Pasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 14 | 04250317546487 | 0314 | 0314 | MassCheck® Methylmalonic Acid Plasma Control Level I | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 15 | 04250317544162 | 0096 | 0096 | Plasma Control Level II, Malondialdeyhde in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 16 | 04250317544148 | 0093 | 0093 | Plasma Control Level II, Coenzyme Q10 | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 17 | 04250317544100 | 0078 | 0078 | Whole blood control Level I, Glutathione in whole blood | Whole Blood Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 18 | 04250317544063 | 0095 | 0095 | Plasma Control Level I, Malondialdeyhde in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 19 | 04250317544056 | 0076 | 0076 | Plasma Control Level II Vitamin C in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 20 | 04250317544049 | 0075 | 0075 | Plasma Control Level I, Vitamin C in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 21 | 04250317544032 | 0092 | 0092 | Plasma Control Level I, Coenzyme Q10 | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 22 | 04250317543929 | 0073 | 0073 | Plasma Control Level II, Homocysteine in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 23 | 04250317543912 | 0072 | 0072 | Plasma Control Level I, Homocysteine in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 24 | 04250317543462 | 0027 | 0027 | Serum Control Level II, ß-Carotene in serum/plasma | Serum Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 25 | 04250317543455 | 0026 | 0026 | Serum Control Level I, ß-Carotene in serum/plasma | Serum Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 26 | 04250317534361 | 0313 | 0313 | MassCheck® Methylmalonic Acid Plasma Control Bi-Level | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 27 | 04250317526038 | 0316 | 0316 | MassCheck® Methylmalonic Acid Urine Control Bi-Level | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 28 | 04250317515650 | 0094 | 0094 | Plasma Control Bi-Level, Malondialdeyhde in plasma/serum | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 29 | 04250317515520 | 0091 | 0091 | Plasma Control Bi-Level, Coenzyme Q10 | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 30 | 04250317515094 | 0077 | 0077 | Whole blood control Bi-Level Glutathione in whole blood | Whole Blood Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 31 | 04250317515049 | 0074 | 0074 | Plasma Control Bi-Level, Vitamin C in plasma/serum | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 32 | 04250317514974 | 0071 | 0071 | Plasma Control Bi-Level Homocysteine in plasma/serum | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 33 | 04250317504234 | 0025 | 0025 | Serum Control Bi-Level, ß-Carotene in serum/plasma | Serum Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 34 | 04051839002921 | 595409943084 | 595409943084 | For use as controls in quantative procedures for β-Hydroxybutyrate | β-Hydroxybutyrate 21 Bi-Level Controls | DIASYS DIAGNOSTIC SYSTEMS GMBH |
| 35 | 04051839002914 | 595709943085 | 595709943085 | For use as controls in quantitative procedures for β-Hydroxybutyrate | β-Hydroxybutyrate 21 Tri-Level Controls | DIASYS DIAGNOSTIC SYSTEMS GMBH |
| 36 | 04049325014879 | 30108902 | 30108902 | Unassayed Testosterone QC Material - 20 mL | Unassayed Testosterone QC Material | IBL INTERNATIONAL GMBH |
| 37 | 04049325006546 | RE62039. | RE62039. | Testosterone Luminescence Immunoassay - 10 x 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
| 38 | 04049325003545 | RE62031 | RE62031 | Testosterone Luminescence Immunoassay - 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
| 39 | 04015630999583 | 5219086160 | 5219086160 | Elecsys Folate III CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 40 | 04015630999477 | 5133181160 | 5133181160 | Elecsys Anti-CCP CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 41 | 04015630999460 | 05129397160 | 05129397160 | Elecsys Anti-TSHR CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 42 | 04015630999026 | 3562140190 | 3562140190 | Elecsys ACTH CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 43 | 04015630999019 | 3149056122 | 3149056122 | Elecsys Anti-Tg CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 44 | 04015630998890 | 4836693160 | 4836693160 | Elecsys Vitamin B12 CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 45 | 04015630997299 | 3554538190 | 3554538190 | Elecsys CalCheck FT 3 | ROCHE DIAGNOSTICS GMBH | |
| 46 | 04015630995462 | 11776860160 | 11776860160 | Elecsys CalCheck Testosterone | ROCHE DIAGNOSTICS GMBH | |
| 47 | 04015630995431 | 11776657160 | 11776657160 | Elecsys CalCheck T-Uptake | ROCHE DIAGNOSTICS GMBH | |
| 48 | 04015630995424 | 11776762160 | 11776762160 | total PSA CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 49 | 04015630995332 | 11776665160 | 11776665160 | Elecsys FT4 CalCheck | ROCHE DIAGNOSTICS GMBH | |
| 50 | 04015630995219 | 3140652122 | 3140652122 | Elecsys beta-CrossLaps CalCheck | ROCHE DIAGNOSTICS GMBH |