| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00860394001249 | CURO G6s Smart Glucose Meter | CURO G6s Smart Glucose Meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CURO G6s Smart Glucose Meter | |
| 2 | 00850006113026 | CURO A1c | CURO A1c Monthly Check Cartridge | LCP,CGA | Assay, Glycosylated Hemoglobin,Glucose Oxidase, Glucose | CURO A1c | ||
| 3 | 00850006113040 | CURO A1c | CURO A1c Daily Check Cartridge | CGA,LCP | Glucose Oxidase, Glucose,Assay, Glycosylated Hemoglobin | 2 | CURO A1c | |
| 4 | 00850006113033 | CURO A1c | Curo A1c Test Cartridge | CGA,LCP | Glucose Oxidase, Glucose,Assay, Glycosylated Hemoglobin | CURO A1c | ||
| 5 | 00860394001263 | CURO G6 Glucose Meter | CURO G6 Glucose Meter | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | CURO G6 Glucose Meter | |
| 6 | 00860394001270 | Curo A1c Analyzer | Curo A1c Analyzer | CGA,LCP | Glucose Oxidase, Glucose,Assay, Glycosylated Hemoglobin | 2 | Curo A1c Analyzer | |
| 7 | 00860394001232 | CURO B3 | CURO B3 Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | CURO B3 | |
| 8 | 00850006113064 | Curo L5 | CURO L5 Glucose Strip | LBR,JJX,JGY,CHH,CGA,NBW | Ldl & Vldl Precipitation, Hdl,Single (Specified) Analyte Controls (Assayed And U Ldl & Vldl Precipitation, Hdl,Single (Specified) Analyte Controls (Assayed And Unassayed),Colorimetric Method, Triglycerides,Enzymatic Esterase--Oxidase, Cholesterol,Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Curo L5 | ||
| 9 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | NBW,CGA,CHH,JGY,JJX,LBR | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose,Enzymatic System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose,Enzymatic Esterase--Oxidase, Cholesterol,Colorimetric Method, Triglycerides,Single (Specified) Analyte Controls (Assayed And Unassayed),Ldl & Vldl Precipitation, Hdl | CURO L5 Total Cholesterol Strips | ||
| 10 | 00860394001294 | CURO Glucose Strips | CURO Glucose Strips for G6 and G6s | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | CURO Glucose Strips |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08809319396512 | 99LS10-2 | CURO L7 Lipid Test Strip - Lipid Profile | SD BIOSENSOR, INC. | ||
| 2 | 08809319396512 | 99LS10-2 | CURO L7 Lipid Test Strip - Lipid Profile | SD BIOSENSOR, INC. | ||
| 3 | 08809319396512 | 99LS10-2 | CURO L7 Lipid Test Strip - Lipid Profile | SD BIOSENSOR, INC. | ||
| 4 | 08809319396161 | 99LA10G-2 | CURO L7 Analyzer | SD BIOSENSOR, INC. | ||
| 5 | 08809319396161 | 99LA10G-2 | CURO L7 Analyzer | SD BIOSENSOR, INC. | ||
| 6 | 08809319396161 | 99LA10G-2 | CURO L7 Analyzer | SD BIOSENSOR, INC. | ||
| 7 | 08809319396161 | 99LA10G-2 | CURO L7 Analyzer | SD BIOSENSOR, INC. | ||
| 8 | 08809317540566 | FREND Vitamin D Linearity Kit | FLK-VTD | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 9 | 08809317540559 | FREND TSH Linearity Kit | FLK-TSH | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 10 | 08809317540542 | FREND Testosterone Linearity Kit | FLK-TES | FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity ma FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Testosterone Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution | FREND | NANOENTEK, INC. |
| 11 | 08809317540535 | FREND PSA Plus Linearity Kit | FLK-PSA | FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity materi FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only.FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 12 | 08809317540528 | FREND Free T4 Linearity Kit | FLK-FT4 | FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity materia FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
| 13 | 08809301168134 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 14 | 08809301168134 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 15 | 08809301168127 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 16 | 08809301168127 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 17 | 08809301168110 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 18 | 08809301168110 | GT-101 | GlucoTrack SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 19 | 08809301168103 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 20 | 08809301168103 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 21 | 08809301168097 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 22 | 08809301168097 | GT-301 | GlucoTrack VOICE Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 23 | 08809301168080 | GT-301 | GlucoTrack Voice Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 24 | 08809301168080 | GT-301 | GlucoTrack Voice Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 25 | 08809301168073 | GT-C03 | GlucoTrack Solution Level 3 | PHILOSYS CO., LTD | ||
| 26 | 08809301168066 | GT-C02 | GlucoTrack Solution Level 2 | PHILOSYS CO., LTD | ||
| 27 | 08809301168059 | GT-C01 | GlucoTrack Solution Level 1 | PHILOSYS CO., LTD | ||
| 28 | 08809301168042 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 29 | 08809301168042 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 30 | 08809301168011 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 31 | 08809301168011 | GT-S01 | GlucoTrack Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 32 | 08809301166031 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 33 | 08809301166031 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 34 | 08809301166017 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 35 | 08809301166017 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 36 | 08809301166000 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 37 | 08809301166000 | PG-101 | Gmate® SMART Blood Glucose Monitoring System | PHILOSYS CO., LTD | ||
| 38 | 08809301162217 | PC003-US | Pip Control Solution High | PHILOSYS CO., LTD | ||
| 39 | 08809301162200 | PC002-US | Pip Control Solution Normal | PHILOSYS CO., LTD | ||
| 40 | 08809301162194 | PC001-US | Pip Control Solution Low | PHILOSYS CO., LTD | ||
| 41 | 08809301162057 | PC-001 | Gmate® Control Solution Level 1 | PHILOSYS CO., LTD | ||
| 42 | 08809301162026 | PC-003 | Gmate® Control Solution Level 3 | PHILOSYS CO., LTD | ||
| 43 | 08809301162019 | PC-002 | Gmate® Control Solution Level 2 | PHILOSYS CO., LTD | ||
| 44 | 08809301161760 | PS-004 | Pip Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 45 | 08809301161760 | PS-004 | Pip Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 46 | 08809301161036 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 47 | 08809301161036 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 48 | 08809301161029 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 49 | 08809301161029 | PS-004 | Gmate® Blood Glucose Test Strips | PHILOSYS CO., LTD | ||
| 50 | 08809301160862 | PG-310 | Pip Blood Glucose Monitoring System | PHILOSYS CO., LTD |