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 | 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 |
39 | 00380740136710 | 08P3640 | 08P3640 | Alinity i Progesterone Manual Diluent | JLS | RADIOIMMUNOASSAY, PROGESTERONE | 1 | Alinity |
40 | 00380740136703 | 07P6731 | 07P6731 | Alinity i B12 Reagent Kit 1200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
41 | 00380740136697 | 07P6721 | 07P6721 | Alinity i B12 Reagent Kit 200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
42 | 00380740136680 | 07P6712 | 07P6712 | Alinity i B12 Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
43 | 00380740136673 | 07P6702 | 07P6702 | Alinity i B12 Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
44 | 00380740136567 | 08P1431 | 08P1431 | Alinity i Folate Reagent Kit 1200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
45 | 00380740136550 | 08P1421 | 08P1421 | Alinity i Folate Reagent Kit 200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
46 | 00380740136543 | 08P1412 | 08P1412 | Alinity i Folate Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
47 | 00380740136536 | 08P1402 | 08P1402 | Alinity i Folate Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
48 | 00380740131647 | 07P4930 | 07P4930 | Alinity i FSH Reagent Kit 1200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
49 | 00380740131630 | 07P4920 | 07P4920 | Alinity i FSH Reagent Kit 200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
50 | 00380740131623 | 07P4910 | 07P4910 | Alinity i FSH Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00812277030068 | 2762-32702 | 2762-32702 | Curaplex Control Solution 2/BT | Curaplex | BOUND TREE MEDICAL, LLC |
2 | 00812242030697 | HBVH202 | HBVH202 | HBV 1E6 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
3 | 00812242030680 | HBVL201 | HBVL201 | HBV 1E3 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
4 | 00812242030673 | HBVP200 | HBVP200 | HBV Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
5 | 00812242030659 | HCVH202 | HCVH202 | HCV 1E6 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
6 | 00812242030642 | HCVL201 | HCVL201 | HCV 1E3 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
7 | 00812242030635 | HCVP200 | HCVP200 | HCV Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
8 | 00812242030611 | CMVH202 | CMVH202 | CMV 5E5 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
9 | 00812242030604 | CMVL201 | CMVL201 | CMV 1E3 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
10 | 00812242030598 | CMVP200 | CMVP200 | CMV Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
11 | 00812242030574 | HIVH202 | HIVH202 | HIV-1 1E5 cp/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
12 | 00812242030567 | HIVL201 | HIVL201 | HIV-1 1E3 cp/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
13 | 00812242030550 | HIVP200 | HIVP200 | HIV-1 Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
14 | 00812242030529 | JCVP100 | JCVP100 | JCV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
15 | 00812242030475 | B19P100 | B19P100 | Parvovirus B19 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
16 | 00812242030444 | HSV2P100 | HSV2P100 | HSV-2 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
17 | 00812242030413 | HSV1P100 | HSV1P100 | HSV-1 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
18 | 00812242030383 | HV6BP100 | HV6BP100 | HHV-6B Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
19 | 00812242030376 | HV6AP100 | HV6AP100 | HHV-6A Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
20 | 00812242030345 | VZVP100 | VZVP100 | VZV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
21 | 00812242030314 | ADVP100 | ADVP100 | Adenovirus Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
22 | 00812242030284 | ZKVP100 | ZKVP100 | Zika Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
23 | 00812242030222 | HBVAMR | HBVAMR | HBV Analytical Measurement Range Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
24 | 00812242030215 | HCVAMR | HCVAMR | HCV Analytical Measurement Range Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
25 | 00812242030208 | HIVAMR | HIVAMR | HIV-1 Analytical Measurement Range Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
26 | 00812242030178 | BKVP100 | BKVP100 | BKV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
27 | 00812242030147 | EBVP100 | EBVP100 | EBV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
28 | 00812242030116 | HBVP100 | HBVP100 | HBV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
29 | 00812242030086 | HCVP100 | HCVP100 | HCV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
30 | 00812242030031 | CMVP100 | CMVP100 | CMV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
31 | 00812242030000 | HIVP100 | HIVP100 | HIV-1 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
32 | 00812137012173 | 2 x 2mL | 502-157 | For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens. | TIBC Calibrator Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
33 | 00811727015594 | L7597-CTL | L7597-CTL | Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitorin Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For in vitro diagnostic use. | Pointe Lipoprotein (a) Control Set | POINTE SCIENTIFIC, INC. |
34 | 00811727011893 | M7562-CAL | M7562-CAL | Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the c Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the calibration of Pointe Scientific’s Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens. For in vitro diagnostic use. | Pointe Scientific, Inc. Microalbumin Calibrator | POINTE SCIENTIFIC, INC. |
35 | 00811727011886 | M7562-100 | M7562-100 | Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use.4 x 20 ml., 2 x 10 ml. | Pointe Scientific, Inc. Microalbumin | POINTE SCIENTIFIC, INC. |
36 | 00811727011657 | I7517-CAL | I7517-CAL | Reagent for calibrating the quantitative Direct Total Iron-Binding Capacity (TIB Reagent for calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. 2 x 1.0ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
37 | 00810042683181 | 702012 | 702012 | HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
38 | 00810042683174 | 18003155 | hCG Low Positive/Negative Urine 2x5mL Kitbox | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
39 | 00810042683129 | 2110005 | 18000347 | CenMed hCG URINE Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
40 | 00810042683112 | 2110007 | 18000346 | CenMed hCG URINE Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
41 | 00810042682962 | 2122015 | 18000698 | CenMed hCG Serum Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
42 | 00810042682948 | 2122017 | 18000697 | CenMed hCG Serum Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
43 | 00810042682900 | Custom QC31 | PREGNANCY SKREEN Custom hCG Serum 4mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
44 | 00810042682894 | Custom QC30 | PREGNANCY SKREEN Custom hCG Serum 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
45 | 00810042681415 | Custom QC25 | PREGNANCY SKREEN Custom hCG Liquid Urine 50mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
46 | 00810042681408 | Custom QC24 | PREGNANCY SKREEN Custom hCG Liquid Urine 20mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
47 | 00810042681392 | Custom QC23 | PREGNANCY SKREEN Custom hCG Liquid Urine 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
48 | 00810042681385 | Custom QC22 | PREGNANCY SKREEN Custom hCG Liquid Urine 2mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
49 | 00810042681347 | Custom QC18 | PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
50 | 00810042681156 | 18030367 | 18030367 | HCG Urine 2x4mL dropper Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |