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 | 07070060014722 | 1116792 | 1116792 | HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert. | Afinion HbA1c Calibration Verification | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
2 | 07070060014661 | 1116975 | 1116975 | HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 C HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 Control C II, 1 package insert. | Afinion HbA1c Control | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
3 | 07070060006505 | 1115178 | 1115178 | HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 Control C1. 1 Control C II. 1 package insert. DI covers Alere Afinion HbA1c Control and Afinion HbA1c Control. | Alere Afinion HbA1c Control | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
4 | 06944904084985 | 105-011385-00 | Urine Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
5 | 06944904084978 | 105-011384-00 | Serum Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
6 | 06438115000112 | 145217 | 145217 | QuikRead go® CRP Control Set is intended for use as assayed quality-control mate QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CRP assay with the QuikRead go Instrument. | QuikRead go® CRP Control set | AIDIAN OY |
7 | 06438115000105 | 145216 | 145216 | QuikRead go® CRP Verification Set is designed to be used for calibration verific QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. It is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. | QuikRead go® CRP Verification set | AIDIAN OY |
8 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
9 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
10 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
11 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
12 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
13 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
14 | 05415168004763 | 08240426190 | 08240426190 | Assayed control for Alpha2-Macroglobulin assay on cobas c501/502 systems. | Alpha2-Macroglobulin Serum CONT KIT | DIAGAM |
15 | 05391516748216 | Tri-stat Liquid Controls Kit | 03-06-0011 | Hemoglobin A1c assay, Tri-stat Liquid Controls Kit | Trinity Biotech | PRIMUS CORPORATION |
16 | 05391516747240 | A7040 | A7040 | ACE CONTROL-E | Trinity Biotech | CLARK LABORATORIES, INC. |
17 | 05391516747233 | A6040 | A6040 | ACE CONTROL-N | Trinity Biotech | CLARK LABORATORIES, INC. |
18 | 05391516741897 | 450-22 | 450-22 | Bile Acids Controls | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
19 | 05391516741866 | 450-11 | 450-11 | Bile Acid Calibrator Set (5 x 5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
20 | 05391516741859 | 450-100 | 450-100 | Bile Acid Calibrator 100 umol/l (5 mL) | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
21 | 05060169695979 | IS-ID6530 | IDS SARS-COV-2 IgG Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
22 | 05060169695825 | IS-2835US | IDS-iSYS Ostase® BAP Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
23 | 05060169695818 | IS-2830US | IDS-iSYS Ostase® BAP Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
24 | 05060169695504 | IS-4620 | IDS Cortisol Calibrator Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
25 | 05060169695306 | IS-2530 | IDS-iSYS 25 VitDS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
26 | 05060169693708 | IS-5635 | IDS SHBG Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
27 | 05060169691339 | IS-5630 | IDS SHBG Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
28 | 05060169691070 | IS-5135 | IDS-iSYS 17-OH Progesterone Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
29 | 05060169691049 | IS-4835 | IDS-iSYS Direct Renin Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
30 | 05060169691001 | IS-4435 | IDS-iSYS Insulin like Growth Factor Binding Protein-3 (IGFBP-3) Cal Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
31 | 05060169690981 | IS-3935 | IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
32 | 05060169690974 | IS-3735 | IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
33 | 05060169690967 | IS-3335 | IDS-iSYS Aldosterone Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
34 | 05060169690950 | IS-3235 | IDS-iSYS Intact PTH Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
35 | 05060169690943 | IS-3035 | IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
36 | 05060169690929 | IS-2535 | IDS-iSYS 25 VitDS Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
37 | 05060169690912 | IS-2435 | IDS-iSYS 1,25-Dihydroxy Vitamin D Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
38 | 05060169690882 | IS-5130 | IDS-iSYS 17-OH Progesterone Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
39 | 05060169690851 | IS-4830 | IDS-iSYS Direct Renin Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
40 | 05060169690820 | IS-4630 | IDS Cortisol Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
41 | 05060169690752 | IS-2530 | IDS-iSYS 25 VitDS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
42 | 05060169690424 | IS-2735S | IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
43 | 05060169690417 | IS-2730S | IDS-iSYS 25-Hydroxy Vitamin DS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
44 | 05060169690370 | IS-3330 | IDS-iSYS Aldosterone Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
45 | 05060169690356 | IS-2430 | IDS-iSYS 1,25-Dihydroxy Vitamin D Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
46 | 05060169690318 | IS-4430 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
47 | 05060169690295 | IS-3930 | IDS-iSYS Insulin like Growth Factor-1 (IGF-I) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
48 | 05060169690271 | IS-3230 | IDS-iSYS Intact PTH Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
49 | 05060169690257 | IS-3030 | IDS-iSYS CTX-I (Crosslaps) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
50 | 05055845400282 | FHBC100/B08176 | FHBC100/B08176 | The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent | AXIS-SHIELD DIAGNOSTICS LIMITED |