No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00630414998947 | 10285226 | LSHCM | SHBG - IMMULITE - CTL - 1x1x2mL | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | IMMULITE® SBG Control SHBG |
2 | 00630414995939 | 10386016 | M15L2 | Trichoderma viride -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Trichoderma viride |
3 | 00630414995922 | 10386017 | M16L2 | Curvularia lunata -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Curvularia lunata |
4 | 00630414995823 | 10386113 | T96L2 | Poplar-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Poplar |
5 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | LYR | Helicobacter pylori | 1 | IMMULITE® Systems HPG CONTROL H.pylori IgG |
6 | 00630414988122 | 10368597 | A89L2 | Native Bet v 1-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nBet v 1 |
7 | 00630414986081 | 10642238 | LSKTI1(D) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | IMMULITE®/IMMULITE® 1000 Systems RTI Turbo Troponin I | |
8 | 00630414984599 | 10485107 | L2SNCCM | Specific IgE Neg - IMMULITE - CTL - 1x4mL | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control |
9 | 00630414984575 | 10485105 | DC2LCM | Specific IgE D2 - IMMULITE - CTL - 1x4mL | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 |
10 | 00630414984452 | 10381168 | LKUE31 | Estriol unconjugated - IMMULITE - RGT - 100 Tests | CGI | RADIOIMMUNOASSAY, ESTRIOL | 1 | IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol |
11 | 00630414979182 | 10386153 | W37L2 | Saltbush-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Saltbush |
12 | 00630414979113 | 10386135 | W14L2 | Rough Pigweed -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Rough Pigweed |
13 | 00630414979021 | 10386092 | T41L2 | White Hickory-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Hickory |
14 | 00630414978994 | 10386088 | T401L2 | Brazilian Peppertree-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Brazilian Peppertree |
15 | 00630414978987 | 10386085 | T37L2 | White Bald Cypress-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Bald Cypress |
16 | 00630414978895 | 10386050 | O201L2 | Tobacco-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tabacco |
17 | 00630414978611 | 10385835 | F50L2 | Chub Mackerel-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Chub Makerel |
18 | 00630414978543 | 10385755 | F261L2 | Asparagus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Asparagus |
19 | 00630414977478 | 10487239 | L2KPF2(D) | fPS Free PSA Kit 200 Test | MTG | Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cance Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | IMMULITE® 2000 Systems fPS Free PSA |
20 | 00630414976686 | 10469593 | LSYCM | Syphillis - IMMULITE - CTL - 2x6mL | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | IMMULITE® Systems SYP CONTROL Syphilis Screen |
21 | 00630414973548 | 10386060 | T15L2 | White Ash -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Ash |
22 | 00630414973326 | 10385714 | F20L2 | Almond -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Almond |
23 | 00630414973227 | 10385774 | F284L2 | Turkey Meat-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Turkey Meat |
24 | 00630414972947 | 10385998 | K84L2 | Sunflower-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Sunflower |
25 | 00630414972527 | 10385789 | F306L2 | Lime-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Lime |
26 | 00630414971377 | 10373705 | LTBCVM | TBG CVM - IMMULITE - CONS | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems TBG Calibration Verification Material TBG |
27 | 00630414971247 | 10373691 | LFT4CVM | Free T4 CVM - IMMULITE - | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems F4 Calibration Verification Material Free T4 |
28 | 00630414971155 | 10373682 | LBRCVM | BR-MA - IMMULITE - CONS | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems BR-MA Calibration Verification Material |
29 | 00630414970677 | 10360575 | A316L2 | Dermatophagoides pteronyssinus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nDer p 2 |
30 | 00630414970653 | 10360573 | A3050L2 | Aspergillus restrictus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nAsp r 1 |
31 | 00630414970103 | 10381630 | LKT31 | T3 Total - IMMULITE - RGT - 100 Tests | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | IMMULITE®/IMMULITE® 1000 Systems T3 Total T3 |
32 | 00630414969343 | 10385667 | E82L4 | Rabbit Epithelium-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Rabbit Epithelium |
33 | 00630414966298 | 10381425 | LKGB1 | IGF BP3 - IMMULITE - RGT - 100 Tests | CFL | RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE | 1 | IMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3 |
34 | 00630414966137 | 10380867 | LKIE1 | IgE - IMMULITE - RGT - 100 Tests | JHR | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) | 2 | IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE |
35 | 00630414965925 | 10386023 | M207L2 | Aspergillus -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Aspergillus niger |
36 | 00630414965680 | 10385960 | I70L2 | Imported Fire Ant -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Imported Fire Ant |
37 | 00630414965598 | 10385718 | F214L2 | Spinach-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Spinach |
38 | 00630414965567 | 10385726 | F221L2 | Coffee-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Coffee |
39 | 00630414965437 | 10386151 | W2L2 | Western Ragweed -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Western Ragweed |
40 | 00630414965383 | 10386131 | W10L2 | Lamb#s Quarters -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Lambs Quarters |
41 | 00630414965376 | 10386130 | TP9L4 | Tree Panel 9 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 9 |
42 | 00630414965369 | 10386128 | TP7L4 | Tree Panel 7 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 7 |
43 | 00630414965352 | 10386126 | TP6L4 | Tree Panel 6 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 6 |
44 | 00630414965338 | 10386122 | TP4L4 | Tree Panel 4 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 4 |
45 | 00630414965154 | 10386057 | T11L2 | Sycamore -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Sycamore |
46 | 00630414965079 | 10386042 | M6L4 | Alternaria tenuis-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Alternaria tenuis |
47 | 00630414964874 | 10380900 | LKVB1 | Vitamin B12 - IMMULITE - RGT - 100 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 |
48 | 00630414964607 | 10381628 | LKRT5 | TSH - IMMULITE - RGT - 500 Tests | JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | 2 | IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH |
49 | 00630414964591 | 10381637 | LKRT1 | TSH - IMMULITE - RGT - 100 Tests | JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | 2 | IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH |
50 | 00630414964331 | 10380969 | LKOP1 | CA 125 - IMMULITE - RGT - 100 Tests | LTK | TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) | 2 | IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00087701866807 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4011-81 | GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
2 | 00087701405570 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | A4011-85 | GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | TRUEtrack | TRIVIDIA HEALTH, INC. |
3 | 00052569132463 | TRUEtrack blood glucose monitoring system | A4089-81 | Health Mart PHARMACY TRUEtrack blood glucose monitoring system | TRUEtrack | TRIVIDIA HEALTH, INC. |
4 | 00050428318010 | TRUEtrack Blood Glucose Monitoring System | A4007-81 | CVS Health TRUEtrack Blood Glucose Monitoring System | TRUEtrack | TRIVIDIA HEALTH, INC. |
5 | 00050428264706 | TRUEtrack Blood Glucose Monitoring System | A4007-81 | CVS Health TRUEtrack Blood Glucose Monitoring System - Meter Kit | TRUEtrack | TRIVIDIA HEALTH, INC. |
6 | 00041415028784 | truetrack ACCURATE BLOOD GLUCOSE METER | A4020-81 | Publix truetrack ACCURATE BLOOD GLUCOSE METER | TRUEtrack | TRIVIDIA HEALTH, INC. |
7 | 00041220842438 | TRUEtrack Blood Glucose Monitoring System | A4031-81 | H-E-B in Control TRUEtrack Blood Glucose Monitoring System | TRUEtrack | TRIVIDIA HEALTH, INC. |
8 | 00030034055479 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4074-81 | GIANT EAGLE TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
9 | 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 | |
10 | 00021292009281 | TRUEtrack Blood Glucose Meter - Free Meter Only | A4088-85 | HealthWise Pharmacy TRUEtrack Blood Glucose Meter - Free Meter Only | TRUEtrack | TRIVIDIA HEALTH, INC. |
11 | 00021292008956 | TRUE FOCUS Self Monitoring Test Strip - 50ct | TRUE FOCUS Self Monitoring Test Strip - 50ct | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
12 | 00021292008932 | TRUEtrack 10 Blood Glucose Test Strips | TRUEtrack 10 Blood Glucose Test Strips | TRUEtrack | TRIVIDIA HEALTH, INC. | |
13 | 00021292008888 | TRUEtrack 25 Blood Glucose Test Strips | TRUEtrack 25 Blood Glucose Test Strips | TRUEtrack | TRIVIDIA HEALTH, INC. | |
14 | 00021292008642 | TRUEtrack 50 Blood Glucose Test Strips | TRUEtrack 50 Blood Glucose Test Strips | TRUEtrack | TRIVIDIA HEALTH, INC. | |
15 | 00021292008444 | TRUE FOCUS Control Solution Level 3 | TRUE FOCUS Control Solution Level 3 | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
16 | 00021292008437 | TRUE FOCUS Control Solution Level 2 | TRUE FOCUS Control Solution Level 2 | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
17 | 00021292008420 | TRUE FOCUS Control Solution Level 1 | TRUE FOCUS Control Solution Level 1 | TRUE FOCUS | TRIVIDIA HEALTH, INC. | |
18 | 00021292008413 | TRUE METRIX Control Solution Level 3 | TRUE METRIX Control Solution Level 3 | TRUE METRIX | TRIVIDIA HEALTH, INC. | |
19 | 00021292008406 | TRUE METRIX Control Solution Level 2 | TRUE METRIX Control Solution Level 2 | TRUE METRIX | TRIVIDIA HEALTH, INC. | |
20 | 00021292008390 | TRUE METRIX Control Solution Level 1 | TRUE METRIX Control Solution Level 1 | TRUE METRIX | TRIVIDIA HEALTH, INC. | |
21 | 00021292008383 | TRUEcontrol Solution Level 0 | TRUEcontrol Solution Level 0 | TRUEcontrol | TRIVIDIA HEALTH, INC. | |
22 | 00021292008376 | TRUEcontrol Solution Level 2 | TRUEcontrol Solution Level 2 | TRUEcontrol | TRIVIDIA HEALTH, INC. | |
23 | 00021292008369 | TRUEcontrol Solution Level 1 | TRUEcontrol Solution Level 1 | TRUEcontrol | TRIVIDIA HEALTH, INC. | |
24 | 00021292004576 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4088-81 | Health Wise PHARMACY TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
25 | 00021292003210 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | A4027-85 | Preferred Plus Pharmacy TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | TRUEtrack | TRIVIDIA HEALTH, INC. |
26 | 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. |
27 | 00021292001797 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | A4H01-88 | TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY | TRUEtrack | TRIVIDIA HEALTH, INC. |
28 | 00021292001261 | TRUEtrack BLOOD GLUCOSE METER | A4027-81 | Preferred Plus Pharmacy TRUEtrack BLOOD GLUCOSE METER | TRUEtrack | TRIVIDIA HEALTH, INC. |
29 | 00021292001018 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4H01-81 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
30 | 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. | |
31 | 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. | |
32 | 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. | |
33 | 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. | |
34 | 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. | |
35 | 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. | |
36 | 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. | |
37 | 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. | |
38 | 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. | |
39 | 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. | |
40 | 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. | |
41 | 00015482500054 | 500005 | Assure Dose Normal (Level 1) Control Solution contains a known amount of glucose 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. (Primary UPC# 015482500054 is used as the assigned UDI for the Class I device.) | Assure® Dose Normal (Level 1) Control Solution | ARKRAY USA, INC. | |
42 | 00011822577540 | TRUEtrack blood glucose monitor | A4066-81 | RITE AID PHARMACY TRUEtrack blood glucose monitor | TRUEtrack | TRIVIDIA HEALTH, INC. |
43 | 00010939755339 | TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | A4054-81 | sunmark TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | TRUEtrack | TRIVIDIA HEALTH, INC. |
44 | B085K021M60 | K021M-6 | Audit MicroControls Control LQ hs-CRP | AALTO SCIENTIFIC | ||
45 | B085K020M60 | K020M-6 | Audit MicroControls Control LQ Homocysteine | AALTO SCIENTIFIC | ||
46 | 50021292008609 | TRUEtrack PRE-PACK | A4002-75 | LEADER TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
47 | 30884389831216 | MPH3560 | MPH3560 | CONTROL,EVENCARE,G3 HI LO,PROF.USE ONLY | Medline | MEDLINE INDUSTRIES, INC. |
48 | 30804084000144 | AGS-1112 | Test Strips a vial of 25 Test Strips | IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test Strips | IDEAL LIFE INC | |
49 | 30014613337713 | 98201 | 98201 | Triage BNP QC Controls | Triage | QUIDEL CARDIOVASCULAR INC. |
50 | 30014613337072 | 98814EU | 98814EU | Triage PLGF Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |