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 | 00884389102544 | MPH1560 | MPH1560 | CONTROL,EVENCARE G2 HI LO | Medline | MEDLINE INDUSTRIES, INC. |
2 | 00883489001924 | Level 2 | RIGHTEST GT333 Control Solution | BIONIME CORPORATION | ||
3 | 00883489001818 | GE333 | GE333 control solution (High level) | GE | BIONIME CORPORATION | |
4 | 00883489001795 | GE333 | GE333 control solution(Normal Level) | GE | BIONIME CORPORATION | |
5 | 00883489001603 | GC300 | Rightest | BIONIME CORPORATION | ||
6 | 00883489001443 | GE100 Control Solution | GE | BIONIME CORPORATION | ||
7 | 00883489001436 | GE100 Control Solution | GE | BIONIME CORPORATION | ||
8 | 00883489001337 | GE100 Control Solution | GE | BIONIME CORPORATION | ||
9 | 00883489001047 | GC300 | Rightest | BIONIME CORPORATION | ||
10 | 00868665000076 | 3S-01-16003A | 3S-01-16003A | Rosie SmartMeter Blood Glucose GDH-FAD Test Strips | Rosie SmartMeter Test Strips 50ct(vial) | HMD BIOMEDICAL INC. |
11 | 00868665000069 | 3C-01-160033 | 3C-01-160033 | Rosie SmartMeter glucose control solution | Rosie SmartMeter Glucose Control Solutions | HMD BIOMEDICAL INC. |
12 | 00860394001294 | CURO Glucose Strips | CURO Glucose Strips for G6 and G6s | CURO Glucose Strips | KPI HEALTHCARE, INC. | |
13 | 00860394001263 | CURO G6 Glucose Meter | CURO G6 Glucose Meter | CURO G6 Glucose Meter | KPI HEALTHCARE, INC. | |
14 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | CURO L5 Total Cholesterol Strips | KPI HEALTHCARE, INC. | |
15 | 00860394001225 | CURO L5 CURO L5 | CURO L5 Cholesterol and Glucose measuring system | CURO L5 | KPI HEALTHCARE, INC. | |
16 | 00860006589721 | 2015-0232 | ACCURUN Anti-SRAS-COV-2 IgM Controls Kit | ACCURUN Anti SARS-COV-2 IgM Controls Kit | LGC CLINICAL DIAGNOSTICS, INC. | |
17 | 00859519002056 | CS | TC0003 | Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips. | BioTel Care® Double Control Solution | TELCARE, LLC |
18 | 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. |
19 | 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. |
20 | 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. |
21 | 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. |
22 | 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. |
23 | 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. |
24 | 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. |
25 | 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. |
26 | 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. |
27 | 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. |
28 | 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. |
29 | 00857969006426 | C2-86 | C2-86 | Hemoglobin A1c Controls | Alfa Wassermann | ALFA WASSERMANN, INC. |
30 | 00857969006273 | SA3007 | SA3007 | T4 Reagent | ACE | ALFA WASSERMANN, INC. |
31 | 00857969006006 | S2-76 | S2-76 | KIT, DIRECT TIBC CALIBRATOR | ACE | ALFA WASSERMANN, INC. |
32 | 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. |
33 | 00856626006212 | 999-61201 | 999-61201 | In-Vitro Diagnostic Use | uTASWako DCP Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
34 | 00856626006168 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
35 | 00856626006106 | 995-06101 | 995-06101 | In-Vitro Diagnostic Use | Autokit Micro Albumin Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
36 | 00856522006095 | 074446 | 074402 | Creatinine Control Kit | Creatinine Control Kit | LIFEHEALTH |
37 | 00856176008032 | 00856176008032 | 00856176008032 | Level 2 Control Solution (150 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
38 | 00856176008025 | 00856176008025 | 00856176008025 | Level 1 Control Solution (75 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
39 | 00855574005391 | HCG-POCU | Qualitative HCG Control, Urine | Poly stat | POLYMEDCO, INC. | |
40 | 00855574005377 | HCG-POC | Qualitative HCG Control | Poly stat | POLYMEDCO, INC. | |
41 | 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. | |
42 | 00854067005238 | EHS-SDMK-V | Smart Diabetes Voice Glucose Monitor | Smart Diabetes | VALUE PROVIDERS LLC | |
43 | 00854067005191 | EHS-SDMK-BT | Smart Diabetes Bluetooth Glucose Monitor | Eocene | VALUE PROVIDERS LLC | |
44 | 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 |
45 | 00853553005202 | Livongo | OFG00426 | Livongo Control Solution with 1 bottle high / 1 bottle low | Livongo Control Solution | LIVONGO HEALTH, INC |
46 | 00853553005158 | In Touch | OFG00155 | In Touch Control solution with 1 bottle high, 1 bottle low | In Touch Glucose Control Solution | LIVONGO HEALTH, INC |
47 | 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 |
48 | 00853553005028 | In Touch | OFG00140 | Box of High/Low Control Solution | In Touch Glucose Control Solutions | LIVONGO HEALTH, INC |
49 | 00853483008199 | VGC01 | VGC01-372 | VivaGuard Ino Control Solution (1 & 3) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
50 | 00853483008175 | VGC01 | VGC01-373 | VivaGuard Ino Control Solution 2 (1 bottle/kit) | VivaGuard Ino | ABLE DIAGNOSTICS INC |