| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00380740194079 | 04Z2135 | 04Z2135 | Alinity i STAT High Sensitivity Troponin-I Reagent Kit 1200 test | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Alinity |
| 2 | 00380740169862 | 03P6834 | 03P6834 | CC MAGNESIUM 3750 Tests | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | 1 | ARCHITECT |
| 3 | 00380740169855 | 03P6824 | 03P6824 | CC MAGNESIUM 1000 Tests | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | 1 | ARCHITECT |
| 4 | 00380740164980 | 04V6201 | 04V6201 | Consolidated Chemistry Calibrator | JIX | Calibrator, multi-analyte mixture | 2 | Alinity |
| 5 | 00380740164973 | 04V1501 | 04V1501 | Consolidated Chemistry Calibrator | JIX | Calibrator, multi-analyte mixture | 2 | ARCHITECT |
| 6 | 00380740160623 | 07P5131 | 07P5131 | Alinity i Total B-hCG Reagent Kit 1200 Tests | DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | 2 | Alinity |
| 7 | 00380740160616 | 07P5121 | 07P5121 | Alinity i Total B-hCG Reagent Kit | DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | 2 | Alinity |
| 8 | 00380740158743 | 04U0930 | 04U0930 | Uric Acid2 2000 Tests | KNK | Acid, uric, uricase (colorimetric) | 1 | Alinity |
| 9 | 00380740158378 | 04U0920 | 04U0920 | Uric Acid2 640 Tests | KNK | Acid, uric, uricase (colorimetric) | 1 | Alinity |
| 10 | 00380740158361 | 04T1330 | 04T1330 | Uric Acid2 2000 Tests | CDO | Acid, uric, uricase (u.V.) | 1 | ARCHITECT |
| 11 | 00380740158354 | 04T1320 | 04T1320 | Uric Acid2 640 Tests | CDO | Acid, uric, uricase (u.V.) | 1 | ARCHITECT |
| 12 | 00380740158064 | 04T8630 | 04T8630 | Aspartate Aminotransferase2 3120 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | Alinity |
| 13 | 00380740158057 | 04T8620 | 04T8620 | Aspartate Aminotransferase2 1200 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | Alinity |
| 14 | 00380740155902 | 04T0030 | 04T0030 | Gamma-Glutamyl Transferase2 2600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | ARCHITECT |
| 15 | 00380740155896 | 04T0020 | 04T0020 | Gamma-Glutamyl Transferase2 600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | ARCHITECT |
| 16 | 00380740155759 | 04T9030 | 04S9030 | Aspartate Aminotransferase2 3960 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | ARCHITECT |
| 17 | 00380740155742 | 04S8830 | 04S8830 | Alanine Aminotransferase2 3960 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | ARCHITECT |
| 18 | 00380740155735 | 04T9020 | 04S9020 | Aspartate Aminotransferase2 1200 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | ARCHITECT |
| 19 | 00380740155728 | 04S8820 | 04S8820 | Alanine Aminotransferase2 1200 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | ARCHITECT |
| 20 | 00380740155711 | 04T8430 | 04T8430 | Alanine Aminotransferase2 3120 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | Alinity |
| 21 | 00380740155704 | 04T8420 | 04T8420 | Alanine Aminotransferase2 1200 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | Alinity |
| 22 | 00380740155476 | 04U4430 | 04U4430 | Total Protein2 3200 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | ARCHITECT |
| 23 | 00380740155469 | 04U4420 | 04U4420 | Total Protein2 800 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | ARCHITECT |
| 24 | 00380740155315 | 04T9630 | 04T9630 | Gamma-Glutamyl Transferase2 2100 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | Alinity |
| 25 | 00380740155308 | 04T9620 | 04T9620 | Gamma-Glutamyl Transferase2 600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | Alinity |
| 26 | 00380740155278 | 04T8130 | 04T8130 | Total Protein2 3120 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | Alinity |
| 27 | 00380740155261 | 04T8120 | 04T8120 | Total Protein2 800 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | Alinity |
| 28 | 00380740146221 | 08P4512 | 08P4512 | Alinity i 25-OH Vitamin D Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
| 29 | 00380740144883 | 07K6437 | 07K6437 | ARCHITECT Total T3 Reagent Kit (500T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 30 | 00380740144876 | 07K6432 | 07K6432 | ARCHITECT Total T3 Reagent Kit (2000T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 31 | 00380740144869 | 07K6427 | 07K6427 | ARCHITECT Total T3 Reagent Kit (100T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 32 | 00380740144845 | 07K6402 | 07K6402 | ARCHITECT Total T3 Calibrators | JIT | Calibrator, secondary | 2 | ARCHITECT |
| 33 | 00380740144838 | 07K6337 | 07K6337 | ARCHITECT Free T3 Reagent Kit (500T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 34 | 00380740144821 | 07K6332 | 07K6332 | ARCHITECT Free T3 Reagent Kit (2000T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 35 | 00380740144814 | 07K6327 | 07K6327 | ARCHITECT Free T3 Reagent Kit (100T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
| 36 | 00380740144807 | 07K6312 | 07K6312 | ARCHITECT Free T3 Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | ARCHITECT |
| 37 | 00380740144791 | 07K6302 | 07K6302 | ARCHITECT Free T3 Calibrators | JIT | Calibrator, secondary | 2 | ARCHITECT |
| 38 | 00380740142759 | 5P02-12 | 05P0212 | ARCHITECT 25-OH Vitamin D Controls | MRG,JJX,JIT | SYSTEM, TEST, VITAMIN D,Single (specified) analyte controls (assayed and unassay SYSTEM, TEST, VITAMIN D,Single (specified) analyte controls (assayed and unassayed),CALIBRATOR, SECONDARY | 1 | ARCHITECT |
| 39 | 00380740142742 | 5P02-02 | 05P0202 | ARCHITECT 25-OH Vitamin D Calibrators | JIT,JJX,MRG | CALIBRATOR, SECONDARY,Single (specified) analyte controls (assayed and unassayed CALIBRATOR, SECONDARY,Single (specified) analyte controls (assayed and unassayed),SYSTEM, TEST, VITAMIN D | 1 | ARCHITECT |
| 40 | 00380740136710 | 08P3640 | 08P3640 | Alinity i Progesterone Manual Diluent | JLS | RADIOIMMUNOASSAY, PROGESTERONE | 1 | Alinity |
| 41 | 00380740136703 | 07P6731 | 07P6731 | Alinity i B12 Reagent Kit 1200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
| 42 | 00380740136697 | 07P6721 | 07P6721 | Alinity i B12 Reagent Kit 200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
| 43 | 00380740136680 | 07P6712 | 07P6712 | Alinity i B12 Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
| 44 | 00380740136673 | 07P6702 | 07P6702 | Alinity i B12 Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
| 45 | 00380740136567 | 08P1431 | 08P1431 | Alinity i Folate Reagent Kit 1200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
| 46 | 00380740136550 | 08P1421 | 08P1421 | Alinity i Folate Reagent Kit 200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
| 47 | 00380740136543 | 08P1412 | 08P1412 | Alinity i Folate Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
| 48 | 00380740136536 | 08P1402 | 08P1402 | Alinity i Folate Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
| 49 | 00380740131647 | 07P4930 | 07P4930 | Alinity i FSH Reagent Kit 1200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
| 50 | 00380740131630 | 07P4920 | 07P4920 | Alinity i FSH Reagent Kit 200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00896863002257 | 1313-31 | 1313-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 3 Set 3x5mL | QUANTIMETRIX CORPORATION |
| 2 | 00896863002240 | 1312-31 | 1312-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 2 Set 3x5mL | QUANTIMETRIX CORPORATION |
| 3 | 00896863002233 | 1311-31 | 1311-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 1 Set 3x5mL | QUANTIMETRIX CORPORATION |
| 4 | 00896863002073 | 1450-01 | 1450-01 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1&2 Set 2x3mL | QUANTIMETRIX CORPORATION |
| 5 | 00896863002066 | 1510-02 | 1510-02 | The Dropper A1c Diabetes Control is intended for the quality control of analytic The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth. | Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL | QUANTIMETRIX CORPORATION |
| 6 | 00896863002059 | 1290-01 | 1290-01 | The Complete D 25-OH Vitamin D control is intended to monitor the performance of The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D. | Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL | QUANTIMETRIX CORPORATION |
| 7 | 00896863002011 | 1452-31 | 1452-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 2 Set 3x3mL | QUANTIMETRIX CORPORATION |
| 8 | 00896863002004 | 1451-31 | 1451-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1 Set 3x3mL | QUANTIMETRIX CORPORATION |
| 9 | 00894046001608 | 005 | 005 | Advocate BMB Control Solutions High | Advocate BMB Control Solutions High | DIABETIC SUPPLY OF SUNCOAST, INC. |
| 10 | 00894046001585 | 003 | BMB003 | Advocate Control Solutions Level 1 Low 4 ml Bottle | Advocate Control Solutions Low | DIABETIC SUPPLY OF SUNCOAST, INC. |
| 11 | 00894030002871 | APX03AB0318 | Embrace TALK Control Solution L1 (LO) | OMNIS HEALTH, LLC | ||
| 12 | 00894030002864 | APX03AB0317 | Embrace TALK control solution L2 | Embrace TALK control solution HI | OMNIS HEALTH, LLC | |
| 13 | 00894030002826 | APX03AB0313HW | HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) | OMNIS HEALTH, LLC | ||
| 14 | 00894030002703 | APX02AB0510 | Embrace Control Solution Low | OMNIS HEALTH | ||
| 15 | 00894030002697 | APX02AB0511 | Embrace Control Solution Hi | OMNIS HEALTH | ||
| 16 | 00894030002680 | APX02AB0502 | Embrace 50ct Test Strip | OMNIS HEALTH | ||
| 17 | 00894030002666 | APX01AB0500VK | Embrace Value Kit (50ct Included) | OMNIS HEALTH | ||
| 18 | 00894030002611 | APX01AB0200N | Embrace Blood Glucose Monitor | OMNIS HEALTH, LLC | ||
| 19 | 00894030002581 | APX02GS0202RF | Embrace Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
| 20 | 00894030002574 | APX02GS0202RF | Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) | OMNIS HEALTH | ||
| 21 | 00894030002567 | APX01GS0200-L | Embrace Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
| 22 | 00894030002550 | APX01GS0200-S | Embrace Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
| 23 | 00894030002543 | APX01AGS0100-SR | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
| 24 | 00894030002536 | APX01AK0200VK | Embrace Meter Value Pack (incl. 50ct) | OMNIS HEALTH | ||
| 25 | 00894030002482 | APX01GS0100-L | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
| 26 | 00894030002475 | APX01GS0100-S | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
| 27 | 00894030002420 | APX01AB0851 | Embrace EVO Mini Meter, all-in-one kit, RETAIL | OMNIS HEALTH | ||
| 28 | 00894030002413 | ALL02AB0210 | Embrace Pro Control Solution (L1/Normal; L2/High) | OMNIS HEALTH | ||
| 29 | 00894030002390 | ALL01AB0200 | Embrace Pro Meter | OMNIS HEALTH | ||
| 30 | 00894030002376 | APX02AB0811 | Embrace EVO Control Solution, L2 (Medium) | OMNIS HEALTH | ||
| 31 | 00894030002345 | APX02AB0810 | Embrace EVO Control Solution, L1 (Low) | OMNIS HEALTH | ||
| 32 | 00894030002260 | APX01AB0300 | Embrace Meter Kit (w/10 ct) | OMNIS HEALTH | ||
| 33 | 00894030002079 | APX02AB310 | Embrace Control Solution, L1 (Low) | OMNIS HEALTH | ||
| 34 | 00894030002062 | APX02AB0311 | Embrace Control Solution, L2 (High) | OMNIS HEALTH | ||
| 35 | 00894030002017 | APX01AB200 | Embrace Meter, Meter Only | OMNIS HEALTH | ||
| 36 | 00894030002000 | APX03AB0300 | Meter Only | Embrace TALK Blood Glucose Monitor | OMNIS HEALTH, LLC | |
| 37 | 00893038002388 | 98202 | 98202 | Alere Triage® BNP Calibrators | Alere Triage® | ALERE SAN DIEGO, INC. |
| 38 | 00893038002371 | 98201 | 98201 | Alere Triage® BNP QC Controls | Alere Triage® | ALERE SAN DIEGO, INC. |
| 39 | 00891237001683 | GOD31 | 1683 | Blood glucose control solution for use with Easy Plus II blood glucose testing system | Easy Plus II Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
| 40 | 00891237001676 | GOD11 | 1676 | Blood glucose control solution for use with Easy Plus II blood glucose testing system | Easy Plus II Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
| 41 | 00891237001522 | GOD31 | 1522 | Blood glucose control solution for use with Easy Talk blood glucose testing system | Easy Talk Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
| 42 | 00891237001492 | GOD11 | 1492 | Blood glucose control solution for use with Easy Talk blood glucose testing system | Easy Talk Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
| 43 | 00891237001461 | 100040005 | 1461 | Blood glucose control solution for use with Trak blood glucose testing system | Easy Trak Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
| 44 | 00891237001454 | 100040006 | 1454 | Blood glucose control solution for use with Easy Trak blood glucose testing system | Easy Trak Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
| 45 | 00891237001232 | T506-66 | 1232 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - HIGH | HOME AIDE DIAGNOSTICS, INC. |
| 46 | 00891237001225 | T506-65 | 1225 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - LOW | HOME AIDE DIAGNOSTICS, INC. |
| 47 | 00891237001201 | T506-64 | 1201 | Blood glucose control solution for use with Easy Step blood glucose testing system | Easy Step Control Solution - NORMAL | HOME AIDE DIAGNOSTICS, INC. |
| 48 | 00888277176747 | MPH5560 | MPH5560 | CNTRL, MINI, NORMAL, SINGLE PATIENT USE | Medline | MEDLINE INDUSTRIES, INC. |
| 49 | 00886338000055 | S5800397 | S5800397 | Level 1 | UASure II Uric Acid Control Solution L1 | APEX BIOTECHNOLOGY CORP. |
| 50 | 00885502016038 | IGM-0008 | IGMHI | EasyGluco™ High Control Solution | U.S. DIAGNOSTICS INC. |