| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00380740200053 | 08P433C | 08P433C | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 2 | 00380740200060 | 09P271B | 09P271B | Alinity i Anti-CCP Assay File | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Alinity |
| 3 | 00380740200046 | 08P435C | 08P435C | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 4 | 00380740200039 | 08P431C | 08P431C | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 5 | 00380740200022 | 08P437C | 08P437C | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 6 | 00380740199487 | 04V511B | 04V511B | Alinity c Total Bilirubin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 7 | 00380740195458 | 07P701C | 07P701C | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 8 | 00380740195380 | 08P181B | 08P181B | Alinity c A-ALT Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 9 | 00380740194208 | 09P523B | 09P523B | Alinity c BenzSQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 10 | 00380740194192 | 09P521B | 09P521B | Alinity c BenzQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 11 | 00380740194093 | 06S611A | 06S611A | Alinity i COV 2IgGII Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 12 | 00380740193638 | 04Z211A | 04Z211A | Alinity i STAT High Sensitivity Tropopnin-I | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 13 | 00380740193577 | 07P701B | 07P701B | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 14 | 00380740192723 | 04U093A | 04U093A | Alinity c Uric2-U Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 15 | 00380740192464 | 06R911A | 06R911A | Alinity i COV-2 IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 16 | 00380740189105 | 08P013B | 08P013B | Alinity c CrEnzU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 17 | 00380740189099 | 08P011B | 08P011B | Alinity c CrEnz Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 18 | 00380740186418 | 04T843A | 04T843A | Alinity c ALT2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 19 | 00380740186401 | 04T841A | 04T841A | Alinity c ALT2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 20 | 00380740186395 | 04T863A | 04T863A | Alinity c AST2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 21 | 00380740186388 | 04T861A | 04T861A | Alinity c AST2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 22 | 00380740186364 | 04U091A | 04U091A | Alinity c Uric2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 23 | 00380740186265 | 04T961A | 04T961A | Alinity c GGT2 Asasy File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 24 | 00380740186159 | 04T811A | 04T811A | Alinity c TPRO2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 25 | 00380740185978 | 07P569A | 07P569A | Alinity c CardiacCRP Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 26 | 00380740185787 | 09P261B | 09P261B | Alinity i Active B12 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 27 | 00380740181000 | 09P533A | 09P533A | Alinity c SerBENZQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 28 | 00380740180201 | 08P433B | 08P433B | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 29 | 00380740180195 | 08P435B | 08P435B | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 30 | 00380740180188 | 08P431B | 08P431B | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 31 | 00380740180171 | 08P437B | 08P437B | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 32 | 00380740180164 | 08P541B | 08P541B | Alinity c Phenytoin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 33 | 00380740180157 | 08P591B | 08P591B | Alinity c Salicylate Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 34 | 00380740180140 | 08P193C | 08P193C | Alinity c MagnesiumU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 35 | 00380740180133 | 08P191C | 08P191C | Alinity c Magnesium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 36 | 00380740180126 | 09P631B | 09P631B | Alinity c IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 37 | 00380740180119 | 08P531D | 08P531D | Alinity c Lithium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 38 | 00380740180089 | 08P041B | 08P041B | Alinity c Microalb Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 39 | 00380740180058 | 08P551B | 08P551B | Alinity c Gentamicin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 40 | 00380740180041 | 09P931B | 09P931B | Alinity c Cerulo Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 41 | 00380740180034 | 07P591B | 07P591B | Alinity c U/CSF Prot Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 42 | 00380740180027 | 07P751B | 07P751B | Alinity c Ultra HDL Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 43 | 00380740180010 | 07P771B | 07P771B | Alinity c Trig Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 44 | 00380740180003 | 09P861B | 09P861B | Alinity c Prealbumin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 45 | 00380740179991 | 07P761B | 07P761B | Alinity c Chol Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 46 | 00380740179984 | 08P021B | 08P021B | Alinity c AlbuminBCG Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 47 | 00380740179977 | 07P691C | 07P691C | Alinity i Free T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 48 | 00380740179960 | 07P941C | 07P941C | Alinity i Total T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 49 | 00380740179571 | 07P567A | 07P567A | Alinity c CRP WR Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| 50 | 00380740179564 | 07P565A | 07P565A | Alinity c CRP HS Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00096295129489 | TRUEtrack Blood Glucose Meter FREE METER ONLY | A4002-85 | LEADER TRUEtrack Blood Glucose Meter – FREE METER ONLY – CANNOT SUBMIT FOR REIMBURSEMENT | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 2 | 00096295129182 | 5277306 | 5277306 | LDR Glucose Control Solution 3x2mL solutions | LEADER | CARDINAL HEALTH 110, INC. |
| 3 | 00096295129144 | 5277181 | 5277181 | LDR Blood Glucose Monitoring System | LEADER | CARDINAL HEALTH 110, INC. |
| 4 | 00096295111866 | TRUEtrack Blood Glucose Monitoring System | A4002-81 | LEADER TRUEtrack Blood Glucose Monitoring System | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 5 | 00093815803126 | 80312 | 80312 | MediSense Glucose & Ketone Control Solutions | MediSense | ABBOTT DIABETES CARE INC |
| 6 | 00093815801399 | 80139 | 80139 | MediSense Glucose & Ketone Control Solutions | MediSense | ABBOTT DIABETES CARE INC |
| 7 | 00093815710653 | 71065 | 71065 | Optium EZ Blood Glucose Monitoring System | OptiumEZ | ABBOTT DIABETES CARE INC |
| 8 | 00093815710424 | 71042 | 71042 | Optium EZ Blood Glucose Test Strips | OptiumEZ | ABBOTT DIABETES CARE INC |
| 9 | 00093815710417 | 71041 | 71041 | Optium EZ Blood Glucose Test Strips | OptiumEZ | ABBOTT DIABETES CARE INC |
| 10 | 00093351115523 | TRUEtrack BLOOD GLUCOSE METER | A4025-81 | DISCOUNT drug mart FOOD FAIR TRUEtrack BLOOD GLUCOSE METER | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 11 | 00087701866807 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4011-81 | GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 12 | 00087701405570 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | A4011-85 | GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 13 | 00052569132463 | TRUEtrack blood glucose monitoring system | A4089-81 | Health Mart PHARMACY TRUEtrack blood glucose monitoring system | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 14 | 00050428318010 | TRUEtrack Blood Glucose Monitoring System | A4007-81 | CVS Health TRUEtrack Blood Glucose Monitoring System | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 15 | 00050428264706 | TRUEtrack Blood Glucose Monitoring System | A4007-81 | CVS Health TRUEtrack Blood Glucose Monitoring System - Meter Kit | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 16 | 00041415028784 | truetrack ACCURATE BLOOD GLUCOSE METER | A4020-81 | Publix truetrack ACCURATE BLOOD GLUCOSE METER | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 17 | 00041220842438 | TRUEtrack Blood Glucose Monitoring System | A4031-81 | H-E-B in Control TRUEtrack Blood Glucose Monitoring System | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 18 | 00030034055479 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4074-81 | GIANT EAGLE TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 19 | 00024291121831 | G115-10D | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Blood Glucose Monitoring System | NAVAJO MANUFACTURING COMPANY | |
| 20 | 00021292009281 | TRUEtrack Blood Glucose Meter - Free Meter Only | A4088-85 | HealthWise Pharmacy TRUEtrack Blood Glucose Meter - Free Meter Only | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 21 | 00021292008956 | TRUE FOCUS Self Monitoring Test Strip - 50ct | TRUE FOCUS Self Monitoring Test Strip - 50ct | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
| 22 | 00021292008932 | TRUEtrack 10 Blood Glucose Test Strips | TRUEtrack 10 Blood Glucose Test Strips | TRUEtrack | TRIVIDIA HEALTH, INC. | |
| 23 | 00021292008888 | TRUEtrack 25 Blood Glucose Test Strips | TRUEtrack 25 Blood Glucose Test Strips | TRUEtrack | TRIVIDIA HEALTH, INC. | |
| 24 | 00021292008642 | TRUEtrack 50 Blood Glucose Test Strips | TRUEtrack 50 Blood Glucose Test Strips | TRUEtrack | TRIVIDIA HEALTH, INC. | |
| 25 | 00021292008444 | TRUE FOCUS Control Solution Level 3 | TRUE FOCUS Control Solution Level 3 | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
| 26 | 00021292008437 | TRUE FOCUS Control Solution Level 2 | TRUE FOCUS Control Solution Level 2 | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
| 27 | 00021292008420 | TRUE FOCUS Control Solution Level 1 | TRUE FOCUS Control Solution Level 1 | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
| 28 | 00021292008413 | TRUE METRIX Control Solution Level 3 | TRUE METRIX Control Solution Level 3 | TRUE METRIX | TRIVIDIA HEALTH, INC. | |
| 29 | 00021292008406 | TRUE METRIX Control Solution Level 2 | TRUE METRIX Control Solution Level 2 | TRUE METRIX | TRIVIDIA HEALTH, INC. | |
| 30 | 00021292008390 | TRUE METRIX Control Solution Level 1 | TRUE METRIX Control Solution Level 1 | TRUE METRIX | TRIVIDIA HEALTH, INC. | |
| 31 | 00021292008383 | TRUEcontrol Solution Level 0 | TRUEcontrol Solution Level 0 | TRUEcontrol | TRIVIDIA HEALTH, INC. | |
| 32 | 00021292008376 | TRUEcontrol Solution Level 2 | TRUEcontrol Solution Level 2 | TRUEcontrol | TRIVIDIA HEALTH, INC. | |
| 33 | 00021292008369 | TRUEcontrol Solution Level 1 | TRUEcontrol Solution Level 1 | TRUEcontrol | TRIVIDIA HEALTH, INC. | |
| 34 | 00021292004576 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4088-81 | Health Wise PHARMACY TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 35 | 00021292003210 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | A4027-85 | Preferred Plus Pharmacy TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 36 | 00021292001971 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM NOT FOR RETAIL SALE | A4H01-87 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM NOT FOR RETAIL SALE | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 37 | 00021292001797 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | A4H01-88 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 38 | 00021292001261 | TRUEtrack BLOOD GLUCOSE METER | A4027-81 | Preferred Plus Pharmacy TRUEtrack BLOOD GLUCOSE METER | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 39 | 00021292001018 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4H01-81 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
| 40 | 00015482740061 | 740006 | GLUCOCARD 01 Control contains a known amount of glucose that reacts with the tes GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482740061 is used as the assigned UDI for the Class I device.) | GLUCOCARD® 01 Control | ARKRAY USA, INC. | |
| 41 | 00015482720056 | 720005 | GLUCOCARD 01 Control contains a known amount of glucose that reacts with the tes GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482720056 is used as the assigned UDI for the Class I device.) | GLUCOCARD® 01 Control | ARKRAY USA, INC. | |
| 42 | 00015482540074 | 540007 | GLUCOCARD Shine Level 2 Control Solution contains a specific amount of glucose t GLUCOCARD Shine Level 2 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540074 is used as the assigned UDI for the Class I device.) | GLUCOCARD® Shine Level 2 Control Solution | ARKRAY USA, INC. | |
| 43 | 00015482540050 | 540005 | GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose t GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.) | GLUCOCARD® Shine Level 1 Control Solution | ARKRAY USA, INC. | |
| 44 | 00015482530068 | 530006 | Assure Prism Control Solution contains a known amount of glucose that reacts wit Assure Prism Control Solution contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482530068 is used as the assigned UDI for the Class I device.) | Assure® Prism Control Solution | ARKRAY USA, INC. | |
| 45 | 00015482510077 | 510007 | For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Co For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. | Assure® Control Level 3 Control Solution (High) | ARKRAY USA, INC. | |
| 46 | 00015482510053 | 510005 | For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Co For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. | Assure® Control Level 2 Control Solution (Normal) | ARKRAY USA, INC. | |
| 47 | 00015482510046 | 510004 | For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Co For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. | Assure® Control Level 1 Control Solution (Low) | ARKRAY USA, INC. | |
| 48 | 00015482502058 | 502005 | Assure® Dose High (Level 2) Control Solution contains a known amount of glucose Assure® Dose High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with CS insert.) | Assure® Dose High (Level 2) Control Solution | ARKRAY USA, INC. | |
| 49 | 00015482502041 | 502004 | Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucos Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with logbook and CS insert.) | Assure® Dose Normal (Level 1) Control Solution | ARKRAY USA, INC. | |
| 50 | 00015482500061 | 500006 | Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known a Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.) | Assure® Dose High (Level 2) Control Solution | ARKRAY USA, INC. |