| 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 | 00894030002376 | APX02AB0811 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Embrace EVO Control Solution, L2 (Medium) | ||
| 6 | 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) | ||
| 7 | 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 | ||
| 8 | 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) | ||
| 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 | 00860394001294 | CURO Glucose Strips | CURO Glucose Strips for G6 and G6s | CURO Glucose Strips | KPI HEALTHCARE, INC. | |
| 2 | 00860394001263 | CURO G6 Glucose Meter | CURO G6 Glucose Meter | CURO G6 Glucose Meter | KPI HEALTHCARE, INC. | |
| 3 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | CURO L5 Total Cholesterol Strips | KPI HEALTHCARE, INC. | |
| 4 | 00860394001225 | CURO L5 CURO L5 | CURO L5 Cholesterol and Glucose measuring system | CURO L5 | KPI HEALTHCARE, INC. | |
| 5 | 00860006589721 | 2015-0232 | ACCURUN Anti-SRAS-COV-2 IgM Controls Kit | ACCURUN Anti SARS-COV-2 IgM Controls Kit | LGC CLINICAL DIAGNOSTICS, INC. | |
| 6 | 00859519002056 | CS | TC0003 | Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips. | BioTel Care® Double Control Solution | TELCARE, LLC |
| 7 | 00859110005951 | 607ro | 607ro | Validate Whole Blood Glucose (WBG) is intended for the quantitative determinatio Validate Whole Blood Glucose (WBG) is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 8 | 00859110005944 | 605to | 605to | 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. |
| 9 | 00859110005937 | 605 | 605 | 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. |
| 10 | 00859110005852 | 506vt | 506vt | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 11 | 00859110005845 | 506ab | 506ab | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 12 | 00859110005838 | 506 | 506 | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 13 | 00859110005715 | 406re | 406re | Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 14 | 00859110005708 | 406bc | 406bc | Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 15 | 00859110005678 | 403ro | 403ro | Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 16 | 00859110005661 | 403ab | 403ab | Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 17 | 00859110005562 | 307 | 307 | Validate Ferritin is intended for the quantitative determination of Calibration Validate Ferritin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
| 18 | 00857969006426 | C2-86 | C2-86 | Hemoglobin A1c Controls | Alfa Wassermann | ALFA WASSERMANN, INC. |
| 19 | 00857596008022 | AC-11 AC302 | 3K-01-16003R | GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type. | GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) | HMD BIOMEDICAL INC. |
| 20 | 00856626006106 | 995-06101 | 995-06101 | In-Vitro Diagnostic Use | Autokit Micro Albumin Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
| 21 | 00856522006095 | 074446 | 074402 | Creatinine Control Kit | Creatinine Control Kit | LIFEHEALTH |
| 22 | 00856176008032 | 00856176008032 | 00856176008032 | Level 2 Control Solution (150 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
| 23 | 00856176008025 | 00856176008025 | 00856176008025 | Level 1 Control Solution (75 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
| 24 | 00855574005391 | HCG-POCU | Qualitative HCG Control, Urine | Poly stat | POLYMEDCO, INC. | |
| 25 | 00855574005377 | HCG-POC | Qualitative HCG Control | Poly stat | POLYMEDCO, INC. | |
| 26 | 00854427007148 | KIT - Glucose Monitoring System | Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lan Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual | HEPRO.US MM1000 Blood Glucose Monitoring System Kit | HEPRO.US INC. | |
| 27 | 00854067005238 | EHS-SDMK-V | Smart Diabetes Voice Glucose Monitor | Smart Diabetes | VALUE PROVIDERS LLC | |
| 28 | 00854067005191 | EHS-SDMK-BT | Smart Diabetes Bluetooth Glucose Monitor | Eocene | VALUE PROVIDERS LLC | |
| 29 | 00853553005257 | Livongo G1.5 | KIT00441 | Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of L Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Welcome Kit | LIVONGO HEALTH, INC |
| 30 | 00853553005202 | Livongo | OFG00426 | Livongo Control Solution with 1 bottle high / 1 bottle low | Livongo Control Solution | LIVONGO HEALTH, INC |
| 31 | 00853553005158 | In Touch | OFG00155 | In Touch Control solution with 1 bottle high, 1 bottle low | In Touch Glucose Control Solution | LIVONGO HEALTH, INC |
| 32 | 00853553005103 | In Touch | KIT00147 | 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch hi 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution | In Touch Refill Kit | LIVONGO HEALTH, INC |
| 33 | 00853553005028 | In Touch | OFG00140 | Box of High/Low Control Solution | In Touch Glucose Control Solutions | LIVONGO HEALTH, INC |
| 34 | 00853483008199 | VGC01 | VGC01-372 | VivaGuard Ino Control Solution (1 & 3) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
| 35 | 00853483008175 | VGC01 | VGC01-373 | VivaGuard Ino Control Solution 2 (1 bottle/kit) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
| 36 | 00853483008076 | VGC01 | VGC01-371 | VivaGuard Ino Control Solution (L, M, H, 1 bottle/each) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
| 37 | 00852668007187 | BLE-CS3 | Control Solution Box 3 Pack | BLE Smart® Control Solution | ENTRA HEALTH SYSTEMS LLC | |
| 38 | 00850578007396 | CT Glucosemeter kits | Case/Carton of 40 boxes of ONE GLUCOSEMETER KIT HEPRO.US MM1000 Copy | HEPRO.US MM1000 BRAND CT40 GLUCOSEMETER KIT - | HEPRO.US INC. | |
| 39 | 00850229007195 | 405 | E002-405 | Analyzer Quality Control | DriDye 405 | AWARENESS TECHNOLOGY, INCORPORATED |
| 40 | 00850229007188 | 405/ 450 | Analyzer Quality Control | DriDye 405/ 450 | AWARENESS TECHNOLOGY, INCORPORATED | |
| 41 | 00850229007171 | 450 | E002-450 | Analyzer Quality Control | DriDye 450 | AWARENESS TECHNOLOGY, INCORPORATED |
| 42 | 00850229007164 | 492 | E002-492 | Analyzer Quality Control | DriDye 492 | AWARENESS TECHNOLOGY, INCORPORATED |
| 43 | 00850212007089 | 2130166 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
| 44 | 00850212007034 | 2130152 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
| 45 | 00850081003212 | MGH-CS3 | Control Solution 3 Pak | MyGlucoHealth® Control Solution 3-Pack | ENTRA HEALTH SYSTEMS LLC | |
| 46 | 00850065006215 | 1054-05 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
| 47 | 00850065006048 | 1054-01 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
| 48 | 00850017460058 | S5800382 | S5800382 | Level 1 & 2 | BIOCOACH Glucose Control Solution L1/L2 | AMVENTUREX, INC. |
| 49 | 00850011135495 | 801mm | aHBs Calibration Verification / Linearity Test kit | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
| 50 | 00850011135457 | 506ro | Validate VIT D Single clinical chemistry analyte IVD, control | VALIDATE | LGC CLINICAL DIAGNOSTICS, INC. |