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| Product | Model | Company | Device type |
|---|---|---|---|
| Assure® Titanium Blood Glucose Test StripsArkray USA, Inc.Glucose monitoring system IVD, point-of-care | 600050 | Arkray USA, Inc. | Glucose monitoring system IVD, point-of-care |
| Assure® Titanium Blood Glucose Test StripsArkray USA, Inc.Glucose monitoring system IVD, point-of-care | 600100 | Arkray USA, Inc. | Glucose monitoring system IVD, point-of-care |
| CuraplexBound Tree Medical, LLCGlucose monitoring system IVD, point-of-care | 670162-KIT-DOD | Bound Tree Medical, LLC | Glucose monitoring system IVD, point-of-care |
| CuraplexBound Tree Medical, LLCGlucose monitoring system IVD, point-of-care | 8600-01458 | Bound Tree Medical, LLC | Glucose monitoring system IVD, point-of-care |
| CuraplexBound Tree Medical, LLCAdhesive bandage | 8600-01165 | Bound Tree Medical, LLC | Adhesive bandage |
| CuraplexBound Tree Medical, LLCFirst aid kit, non-medicated, reusable | 8600-01172 | Bound Tree Medical, LLC | First aid kit, non-medicated, reusable |
| CuraplexBound Tree Medical, LLCBlood lancet, single-use | 8600-LANCTS-1323 | Bound Tree Medical, LLC | Blood lancet, single-use |
| CuraplexBound Tree Medical, LLCAdhesive bandage | 8600-01182 | Bound Tree Medical, LLC | Adhesive bandage |
| Easy Plus II Blood Glucose Monitoring SystemHome Aide Diagnostics, Inc.Glucose monitoring system IVD, home-use | 6276 | Home Aide Diagnostics, Inc. | Glucose monitoring system IVD, home-use |
| Easy@Home EBG-100BLE blood glucose monitoring systemHmd Biomedical Inc.Glucose IVD, kit, electrometry | 3K-01-25003G | Hmd Biomedical Inc. | Glucose IVD, kit, electrometry |
| FreeStyle Precision NeoAbbott Diabetes Care IncMultiple clinical chemistry analyte monitoring system IVD, home-use | 71577 | Abbott Diabetes Care Inc | Multiple clinical chemistry analyte monitoring system IVD, home-use |
| FreeStyle Precision ProAbbott Diabetes Care IncMultiple clinical chemistry analyte monitoring system IVD, point-of-care | 71284 | Abbott Diabetes Care Inc | Multiple clinical chemistry analyte monitoring system IVD, point-of-care |
| GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPSArkray USA, Inc.Glucose monitoring system IVD, home-use | 740050 | Arkray USA, Inc. | Glucose monitoring system IVD, home-use |
| GLUCOCARD® EXPRESSION Blood Glucose Test StripsArkray USA, Inc.Glucose monitoring system IVD, home-use | 570050 | Arkray USA, Inc. | Glucose monitoring system IVD, home-use |
| McKessonMckesson Medical-Surgical Inc.Home-use blood glucose spot-check system | 06-R3051-41 | Mckesson Medical-Surgical Inc. | Home-use blood glucose spot-check system |
| ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.Multiple clinical chemistry analyte monitoring system IVD, home-use | OGS-511 | Acon Laboratories, Inc. | Multiple clinical chemistry analyte monitoring system IVD, home-use |
| OneTouch Ultra Plus FlexLifeScan Europe GmbHGlucose monitoring system IVD, home-use | 024-270 | LifeScan Europe GmbH | Glucose monitoring system IVD, home-use |
| OptiScanner 5000 Disposable CartridgeOptiscan Biomedical CorporationPoint-of-care blood glucose monitoring system | 5000 | Optiscan Biomedical Corporation | Point-of-care blood glucose monitoring system |
| OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical CorporationPoint-of-care blood glucose monitoring system | 5000 | Optiscan Biomedical Corporation | Point-of-care blood glucose monitoring system |
| Precision XtraAbbott Diabetes Care IncMultiple clinical chemistry analyte monitoring system IVD, home-use | 70746 | Abbott Diabetes Care Inc | Multiple clinical chemistry analyte monitoring system IVD, home-use |
| StatSensor StatStripNova Biomedical CorporationGlucose monitoring system IVD, point-of-care | Gen 2.0 | Nova Biomedical Corporation | Glucose monitoring system IVD, point-of-care |
| STATSTRIPNova Biomedical CorporationGlucose monitoring system IVD, point-of-care | 1.75 | Nova Biomedical Corporation | Glucose monitoring system IVD, point-of-care |
| STATSTRIPNova Biomedical CorporationGlucose monitoring system IVD, point-of-care | 1.75 | Nova Biomedical Corporation | Glucose monitoring system IVD, point-of-care |
| Teladoc Health, Inc.Teladoc Health, Inc.Glucose analyser IVD, home-use | BG500 RD | Teladoc Health, Inc. | Glucose analyser IVD, home-use |
| Tyson Bio HT100 Blood Glucose MeterTyson Bioresearch Inc.Glucose monitoring system IVD, home-use | HT100 | Tyson Bioresearch Inc. | Glucose monitoring system IVD, home-use |