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 | 00896863002257 | 1313-31 | 1313-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 3 Set 3x5mL | QUANTIMETRIX CORPORATION |
2 | 00896863002240 | 1312-31 | 1312-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 2 Set 3x5mL | QUANTIMETRIX CORPORATION |
3 | 00896863002233 | 1311-31 | 1311-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 1 Set 3x5mL | QUANTIMETRIX CORPORATION |
4 | 00896863002073 | 1450-01 | 1450-01 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1&2 Set 2x3mL | QUANTIMETRIX CORPORATION |
5 | 00896863002066 | 1510-02 | 1510-02 | The Dropper A1c Diabetes Control is intended for the quality control of analytic The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth. | Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL | QUANTIMETRIX CORPORATION |
6 | 00896863002059 | 1290-01 | 1290-01 | The Complete D 25-OH Vitamin D control is intended to monitor the performance of The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D. | Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL | QUANTIMETRIX CORPORATION |
7 | 00896863002011 | 1452-31 | 1452-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 2 Set 3x3mL | QUANTIMETRIX CORPORATION |
8 | 00896863002004 | 1451-31 | 1451-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1 Set 3x3mL | QUANTIMETRIX CORPORATION |
9 | 00894046001608 | 005 | 005 | Advocate BMB Control Solutions High | Advocate BMB Control Solutions High | DIABETIC SUPPLY OF SUNCOAST, INC. |
10 | 00894046001585 | 003 | BMB003 | Advocate Control Solutions Level 1 Low 4 ml Bottle | Advocate Control Solutions Low | DIABETIC SUPPLY OF SUNCOAST, INC. |
11 | 00894030002871 | APX03AB0318 | Embrace TALK Control Solution L1 (LO) | OMNIS HEALTH, LLC | ||
12 | 00894030002864 | APX03AB0317 | Embrace TALK control solution L2 | Embrace TALK control solution HI | OMNIS HEALTH, LLC | |
13 | 00894030002826 | APX03AB0313HW | HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) | OMNIS HEALTH, LLC | ||
14 | 00894030002703 | APX02AB0510 | Embrace Control Solution Low | OMNIS HEALTH | ||
15 | 00894030002697 | APX02AB0511 | Embrace Control Solution Hi | OMNIS HEALTH | ||
16 | 00894030002680 | APX02AB0502 | Embrace 50ct Test Strip | OMNIS HEALTH | ||
17 | 00894030002666 | APX01AB0500VK | Embrace Value Kit (50ct Included) | OMNIS HEALTH | ||
18 | 00894030002611 | APX01AB0200N | Embrace Blood Glucose Monitor | OMNIS HEALTH, LLC | ||
19 | 00894030002581 | APX02GS0202RF | Embrace Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
20 | 00894030002574 | APX02GS0202RF | Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) | OMNIS HEALTH | ||
21 | 00894030002567 | APX01GS0200-L | Embrace Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
22 | 00894030002550 | APX01GS0200-S | Embrace Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
23 | 00894030002543 | APX01AGS0100-SR | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
24 | 00894030002536 | APX01AK0200VK | Embrace Meter Value Pack (incl. 50ct) | OMNIS HEALTH | ||
25 | 00894030002482 | APX01GS0100-L | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
26 | 00894030002475 | APX01GS0100-S | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
27 | 00894030002420 | APX01AB0851 | Embrace EVO Mini Meter, all-in-one kit, RETAIL | OMNIS HEALTH | ||
28 | 00894030002413 | ALL02AB0210 | Embrace Pro Control Solution (L1/Normal; L2/High) | OMNIS HEALTH | ||
29 | 00894030002390 | ALL01AB0200 | Embrace Pro Meter | OMNIS HEALTH | ||
30 | 00894030002376 | APX02AB0811 | Embrace EVO Control Solution, L2 (Medium) | OMNIS HEALTH | ||
31 | 00894030002345 | APX02AB0810 | Embrace EVO Control Solution, L1 (Low) | OMNIS HEALTH | ||
32 | 00894030002260 | APX01AB0300 | Embrace Meter Kit (w/10 ct) | OMNIS HEALTH | ||
33 | 00894030002079 | APX02AB310 | Embrace Control Solution, L1 (Low) | OMNIS HEALTH | ||
34 | 00894030002062 | APX02AB0311 | Embrace Control Solution, L2 (High) | OMNIS HEALTH | ||
35 | 00894030002017 | APX01AB200 | Embrace Meter, Meter Only | OMNIS HEALTH | ||
36 | 00894030002000 | APX03AB0300 | Meter Only | Embrace TALK Blood Glucose Monitor | OMNIS HEALTH, LLC | |
37 | 00893038002371 | 98201 | 98201 | Alere Triage® BNP QC Controls | Alere Triage® | ALERE SAN DIEGO, INC. |
38 | 00891237001683 | GOD31 | 1683 | Blood glucose control solution for use with Easy Plus II blood glucose testing system | Easy Plus II Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
39 | 00891237001676 | GOD11 | 1676 | Blood glucose control solution for use with Easy Plus II blood glucose testing system | Easy Plus II Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
40 | 00891237001522 | GOD31 | 1522 | Blood glucose control solution for use with Easy Talk blood glucose testing system | Easy Talk Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
41 | 00891237001492 | GOD11 | 1492 | Blood glucose control solution for use with Easy Talk blood glucose testing system | Easy Talk Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
42 | 00891237001461 | 100040005 | 1461 | Blood glucose control solution for use with Trak blood glucose testing system | Easy Trak Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
43 | 00891237001454 | 100040006 | 1454 | Blood glucose control solution for use with Easy Trak blood glucose testing system | Easy Trak Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
44 | 00891237001232 | T506-66 | 1232 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
45 | 00891237001225 | T506-65 | 1225 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
46 | 00891237001201 | T506-64 | 1201 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - NORMAL | HOME AIDE DIAGNOSTICS, INC. |
47 | 00888277176747 | MPH5560 | MPH5560 | CNTRL, MINI, NORMAL, SINGLE PATIENT USE | Medline | MEDLINE INDUSTRIES, INC. |
48 | 00886338000055 | S5800397 | S5800397 | Level 1 | UASure II Uric Acid Control Solution L1 | APEX BIOTECHNOLOGY CORP. |
49 | 00885502016038 | IGM-0008 | IGMHI | EasyGluco™ High Control Solution | U.S. DIAGNOSTICS INC. | |
50 | 00885502016007 | IGM-0024 | INFINITY™ High Control Solution | U.S. DIAGNOSTICS INC. |