| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00894030002697 | APX02AB0511 | 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 | Embrace Control Solution Hi | ||
| 2 | 00894030002666 | APX01AB0500VK | 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 | Embrace Value Kit (50ct Included) | ||
| 3 | 00894030002543 | APX01AGS0100-SR | 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 | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | ||
| 4 | 00894030002536 | APX01AK0200VK | 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 | Embrace Meter Value Pack (incl. 50ct) | ||
| 5 | 00894030002482 | APX01GS0100-L | 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 | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | ||
| 6 | 00894030002017 | APX01AB200 | 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 | Embrace Meter, Meter Only | ||
| 7 | 00894030002581 | APX02GS0202RF | 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 | Embrace Gestational Diabetes Package - RETAIL (5 vials) | ||
| 8 | 00894030002413 | ALL02AB0210 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Pro Control Solution (L1/Normal; L2/High) | ||
| 9 | 00894030002703 | APX02AB0510 | 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 | Embrace Control Solution Low | ||
| 10 | 00894030002574 | APX02GS0202RF | 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 | Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) | ||
| 11 | 00894030002475 | APX01GS0100-S | 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 | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | ||
| 12 | 00894030002420 | APX01AB0851 | 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 | Embrace EVO Mini Meter, all-in-one kit, RETAIL | ||
| 13 | 00894030002345 | APX02AB0810 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace EVO Control Solution, L1 (Low) | ||
| 14 | 00894030002079 | APX02AB310 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Control Solution, L1 (Low) | ||
| 15 | 00894030002024 | APX02AB0202 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 50ct Vial - Distributor partner | ||
| 16 | 00894030002086 | APX02AB0200 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 10-ct | ||
| 17 | 00894030002062 | APX02AB0311 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace Control Solution, L2 (High) | ||
| 18 | 00894030002352 | APX02AB0802 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace EVO Strips, 50ct Vial - RETAIL | ||
| 19 | 00894030002338 | APX02AB0202MO | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Strips, 50ct Vial - Mail Order (Yellow Band) | ||
| 20 | 00894030002680 | APX02AB0502 | 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 | Embrace 50ct Test Strip | ||
| 21 | 00894030002406 | ALL02AB0202 | LFR | Glucose Dehydrogenase, Glucose | 2 | Embrace Pro Strips, 50-ct vials | ||
| 22 | 00894030002390 | ALL01AB0200 | 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 | Embrace Pro Meter | ||
| 23 | 00894030002260 | APX01AB0300 | 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 | Embrace Meter Kit (w/10 ct) | ||
| 24 | 00894030002567 | APX01GS0200-L | 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 | Embrace Gestational Diabetes Package - LARGE (9 vials) | ||
| 25 | 00894030002550 | APX01GS0200-S | 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 | Embrace Gestational Diabetes Package - SMALL (5 vials) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10673486000719 | Glucopad Blood Glucose Monitoring System | G852-C-001 | Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it c Glucopad Blood Glucose Monitoring System (BGMS) is for self testing use and it consists of a blood glucose meter, and blood glucose test strips. | TECO DIAGNOSTICS | TECO DIAGNOSTICS |
| 2 | 10385542013013 | 8000-02013 | Control Solution, AgaMatrix, High | AgaMatrix | AGAMATRIX, INC. | |
| 3 | 10385541335017 | 8000-01335 | Control Solution, AgaMatrix, Normal | AgaMatrix | AGAMATRIX, INC. | |
| 4 | 10385541003503 | 8000-10520 | Control Solution, AgaMatrix, Level 4 | AgaMatrix | AGAMATRIX, INC. | |
| 5 | 10385541003305 | 8000-10519 | Control Solution, AgaMatrix, Level 2 | AgaMatrix | AGAMATRIX, INC. | |
| 6 | 10301937315012 | 7315 | 7315 | Control Solution - Level 1. 1 x 2.5 mL. | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. |
| 7 | 10301937314015 | 7314 | 7314 | Control Solution - Level 2. 1 x 2.5 mL. | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. |
| 8 | 10301937111010 | 7111B | 7111B | Control Solution - High, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
| 9 | 10301937110013 | 7110B | 7110B | Control Solution - Low, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
| 10 | 10301937109017 | 7109B | 7109B | Control Solution - Normal, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
| 11 | 10301931491019 | 1491A | 1491A | Control Solution - High, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
| 12 | 10301931490012 | 1490A | 1490A | Control Solution - Low, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
| 13 | 10301931489016 | 1489A | 1489A | Control Solution - Normal, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
| 14 | M52551390 | 5139 | Alkaline Phosphatase Isoenzyme Control (1 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
| 15 | M52551040 | 5104 | Gel Alk Phosphatase Isoenzyme Control (1 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
| 16 | M52532180 | 3218 | REP Cholesterol Profile Control (5 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
| 17 | 10052569138479 | TRUEtrack PRE-PACK | A4089-75 | Health Mart PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 18 | 10021292008625 | TRUEtrack PRE-PACK | A4027-75 | Preferred Plus Pharmacy TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 19 | 10021292008618 | TRUEtrack PRE-PACK | A4011-75 | GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 20 | 10021292006874 | TRUEtrack PRE-PACK | A4088-75 | HealthWise PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 21 | 10021292006867 | TRUEtrack PRE-PACK | A4054-75 | Sunmark TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 22 | 10021292006843 | TRUEtrack PRE-PACK | A4H01-75 | TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 23 | 09421902348112 | 107253 | HB510Ar | The lypholised Hemoglobin A1c Linearity controls are prepared from human blood a The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced stability.The Lyophilized Hemoglobin A1c Linearity Controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols setup within individual clinical laboratories. | ExtendSure | CANTERBURY SCIENTIFIC LIMITED |
| 24 | 09421902348099 | B12397 | The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and leve The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 25 | 09421902348082 | HB510 | The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, 3, 4 and 5 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 26 | 09421902348075 | HB710SBAr | The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and l The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 27 | 09421902348068 | 220232 | Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reco Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert | TOSOH | CANTERBURY SCIENTIFIC LIMITED | |
| 28 | 09421902348006 | B12396 | The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
| 29 | 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. |
| 30 | 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. |
| 31 | 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. |
| 32 | 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. |
| 33 | 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. |
| 34 | 08809301168073 | GT-C03 | GlucoTrack Solution Level 3 | PHILOSYS CO., LTD | ||
| 35 | 08809301168066 | GT-C02 | GlucoTrack Solution Level 2 | PHILOSYS CO., LTD | ||
| 36 | 08809301168059 | GT-C01 | GlucoTrack Solution Level 1 | PHILOSYS CO., LTD | ||
| 37 | 08809301162217 | PC003-US | Pip Control Solution High | PHILOSYS CO., LTD | ||
| 38 | 08809301162200 | PC002-US | Pip Control Solution Normal | PHILOSYS CO., LTD | ||
| 39 | 08809301162194 | PC001-US | Pip Control Solution Low | PHILOSYS CO., LTD | ||
| 40 | 08809301162057 | PC-001 | Gmate® Control Solution Level 1 | PHILOSYS CO., LTD | ||
| 41 | 08809301162026 | PC-003 | Gmate® Control Solution Level 3 | PHILOSYS CO., LTD | ||
| 42 | 08809301162019 | PC-002 | Gmate® Control Solution Level 2 | PHILOSYS CO., LTD | ||
| 43 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Meter | OSANG HEALTHCARE CO., LTD. | |
| 44 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | Element™ Meter | OSANG HEALTHCARE CO., LTD. | |
| 45 | 08809115906533 | IGM-1003F | blood glucose meter and test strip control solution-level 3 | Oh'Care Lite Smart Glucose control solution-Level 3 | OSANG HEALTHCARE CO., LTD. | |
| 46 | 08809115906526 | IGM-1003F | blood glucose meter and test strip control solution-Level 2 | Oh'Care Lite Smart Glucose control solution-Level 2 | OSANG HEALTHCARE CO., LTD. | |
| 47 | 08809115906519 | IGM-1003F | blood glucose meter and test strip control solution level 1 | Oh'Care Lite Smart Glucose control solution-Level 1 | OSANG HEALTHCARE CO., LTD. | |
| 48 | 08806679002718 | CFPC-15 | CFPC-15 | ichroma™ iFOB | BODITECH MED INC. | |
| 49 | 08806128340064 | AGM-4000 | Embrace Pro Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
| 50 | 08806128340019 | AGM-4000 | Embrace Pro Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. |