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 | 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 | 00850017460058 | S5800382 | S5800382 | Level 1 & 2 | BIOCOACH Glucose Control Solution L1/L2 | AMVENTUREX, INC. |
2 | 00850011135495 | 801mm | aHBs Calibration Verification / Linearity Test kit | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
3 | 00850011135457 | 506ro | Validate VIT D Single clinical chemistry analyte IVD, control | VALIDATE | LGC CLINICAL DIAGNOSTICS, INC. | |
4 | 00850011135402 | 510mm | Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
5 | 00850011135372 | 908bc | Validate THY2 IVD Control | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
6 | 00850011135327 | 605sa | 605sa | Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
7 | 00850011135310 | 509ro | 509ro | Validate IL-6 is intended for the quantitative determination of Calibration Veri Validate IL-6 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
8 | 00850011135280 | 405ab | 405ab | Validate High Sensitive Troponin I is intended for the quantitative determinatio Validate High Sensitive Troponin I is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
9 | 00850011135259 | 303ro | 303ro | Validate PTH is intended for the quantitative determination of Calibration Verif Validate PTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
10 | 00850011135211 | 302mm | 302mm | Validate ACTH is intended for the quantitative determination of Calibration Veri Validate ACTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
11 | 00850006113064 | Curo L5 | CURO L5 Glucose Strip | Curo L5 | KPI HEALTHCARE, INC. | |
12 | 00850004812242 | 702013 | 702013 | Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Contr Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Control, 5mL Kitbox | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
13 | 00850001462419 | v1 | GOJJI KETONE CONTROL SOLUTION-L1 | GOJJI, INC. | ||
14 | 00850001462402 | v1 | GOJJI GLUCOSE CONTROL SOLN-NORMAL | GOJJI, INC. | ||
15 | 00847865011648 | 6633740 | 6633740 | 25-OH Vitamin D Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
16 | 00847865011631 | 6633730 | 6633730 | 25-OH Vitamin D Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
17 | 00847865010894 | 6632240 | 6632240 | Celiac IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
18 | 00847865010887 | 6632340 | 6632340 | Celiac IgA Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
19 | 00847865010627 | 6632230 | 6632230 | Celiac IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
20 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
21 | 00847865001168 | 6633840 | 6633840 | Rubella & CMV IgM Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
22 | 00847865001151 | 6633830 | 6633830 | Rubella & CMV Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
23 | 00847865000703 | 6632140 | 6632140 | APLS IgA Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
24 | 00847865000697 | 6632130 | 6632130 | APLS IgA Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
25 | 00847865000659 | 6632040 | 6632040 | APLS IgM Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
26 | 00847865000642 | 6632030 | 6632030 | APLS IgM Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
27 | 00847865000598 | 6631940 | 6631940 | APLS IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
28 | 00847865000581 | 6631930 | 6631930 | APLS IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
29 | 00847717034009 | TRUEtrack Blood Glucose Meter Medidor de Glucosa en la Sangre | A4092-81 | Vida Mia mi salud TRUEtrack Blood Glucose Meter Medidor de Glucosa en la Sangre | TRUEtrack | TRIVIDIA HEALTH, INC. |
30 | 00847661004639 | 288X | 288X | Liquichek Homocysteine Control MiniPak (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
31 | 00847661004622 | 289 | 289 | Liquichek Homocysteine Control Level 3 (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
32 | 00847661004615 | 288 | 288 | Liquichek Homocysteine Control Level 2 (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
33 | 00847661004608 | 287 | 287 | Liquichek Homocysteine Control Level 1 (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
34 | 00847661004301 | 292X | 292X | Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabete Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
35 | 00847661004295 | 293 | 293 | Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
36 | 00847661004288 | 292 | 292 | Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
37 | 00847661004271 | 291 | 291 | Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
38 | 00847661001768 | 255X | 255X | Liquichek Elevated CRP Control MiniPak (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
39 | 00847661000938 | 256 | 256 | Liquichek Elevated CRP Control Level 3 (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
40 | 00847661000921 | 255 | 255 | Liquichek Elevated CRP Control Level 2 (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
41 | 00847661000914 | 254 | 254 | Liquichek Elevated CRP Control Level 1 (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
42 | 00844509001003 | 285536 | 285536 | A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linear A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter. | A1c-Cellular Linearity | STRECK, INC. |
43 | 00844509000945 | 211130 | 211130 | A liquid control appropriate for immunoassay and ionic exchange HPLC methodologi A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2. | A1c-Cellular | STRECK, INC. |
44 | 00844509000938 | 211124 | 211124 | A liquid control appropriate for immunoassay and ionic exchange HPLC methodologi A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2. | A1c-Cellular | STRECK, INC. |
45 | 00842768037535 | 10707958 | KC683 | LOCI Cardiac Troponin-I Control (high), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON H | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00842768037528 | 10707957 | KC682 | LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00842768037511 | 10707956 | KC681 | LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON L | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00842768032615 | 10483822 | DF105A | Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator | Dimension® Flex Reagent Cartridge HB1C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00842768022685 | 10733022 | 10733022 | Anti-HBe2 (aHBe2) – Atellica IM – QC Kit | Atellica IM aHBe2 QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00842768007248 | 10446040 | OQCW05 | Assayed control for Lp(a) assay on BN Systems | N Lp(a) Control SY | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |