No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10758750034895 | 6177750 | 6177750 | VITROS Immunodiagnostic ProductsAFP Calibrators | JIS | Calibrator, primary | 2 | VITROS |
2 | 10758750034819 | 6177745 | 6177745 | VITROS Immunodiagnostic Products AFP Reagent Pack | LOJ | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER | 2 | VITROS |
3 | 10758750034659 | 6199330 | 6199330 | VITROS Immunodiagnostic ProductsProlactin Calibrators | JIS | Calibrator, primary | 2 | VITROS |
4 | 10758750034420 | 6199961 | 6199961 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
5 | 10758750034413 | 6199960 | 6199960 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
6 | 10758750034321 | 6199337 | 6199337 | VITROS Immunodiagnostic Products Prolactin Reagent Pack | CFT | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) | 1 | VITROS |
7 | 10758750034314 | 6199336 | 6199336 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | VITROS |
8 | 10758750033409 | 6199924 | 6199924 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls | QKO | Reagent, coronavirus serological | VITROS | |
9 | 10758750033393 | 6199923 | 6199923 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
10 | 10758750033386 | 6199922 | 6199922 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
11 | 10758750033379 | 6199921 | 6199921 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls | QKO | Reagent, coronavirus serological | VITROS | |
12 | 10758750033362 | 6199920 | 6199920 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
13 | 10758750033355 | 6199919 | 6199919 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
14 | 10758750033317 | 6192256 | 6192256 | VITROS Immunodiagnostic Products NT-proBNP II Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
15 | 10758750033300 | 6192255 | 6192255 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | NBC | Test, natriuretic peptide | 2 | VITROS |
16 | 10758750033294 | 6195575 | 6195575 | VITROS Immunodiagnostic Products BRAHMS PCT Calibrator | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
17 | 10758750033287 | 6197735 | 6197735 | VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
18 | 10758750033195 | 691 2265 | 691 2265 | VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
19 | 10758750033171 | 691 2263 | 691 2263 | VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
20 | 10758750033164 | 691 2261 | 691 2261 | VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
21 | 10758750032945 | 6905561 | 6905561 | VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
22 | 10758750032938 | 6905560 | 6905560 | VITROS Immunodiagnostic Products BRAHMS PCT Controls | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
23 | 10758750032068 | 6844425 | 6844425 | VITROS Immunodiagnostic Products Insulin Reagent Pack | CFP | RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN | 1 | VITROS |
24 | 10758750032051 | 6844424 | 6844424 | VITROS Immunodiagnostic Products C-peptide Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
25 | 10758750032044 | 6844426 | 6844426 | VITROS Immunodiagnostic Products Insulin Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
26 | 10758750032037 | 6844423 | 6844423 | VITROS Immunodiagnostic Products C-peptide Reagent Pack | JKD | RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN | 1 | VITROS |
27 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | MZF | Test, hiv detection | 2 | VITROS |
28 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | MZF | Test, hiv detection | 2 | VITROS |
29 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | VITROS |
30 | 10758750030200 | 6844055 | 6844055 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
31 | 10758750009541 | 1681543 | 1681543 | VITROS Immunodiagnostic Products Cortisol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
32 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
33 | 10758750009404 | 1614965 | 1614965 | VITROS Immunodiagnostic Products Total T3 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
34 | 10758750009367 | 1540525 | 1540525 | VITROS Immunodiagnostic Products Vitamin B12 Calibrators | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
35 | 10758750009237 | 1513266 | 1513266 | VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | VITROS |
36 | 10758750009145 | 1471481 | 1471481 | VITROS Immunodiagnostic Products T3 Uptake Reagent Pack | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | 2 | VITROS |
37 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
38 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | VITROS |
39 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
40 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
41 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
42 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | CEC | RADIOIMMUNOASSAY, FREE THYROXINE | 2 | VITROS |
43 | 10758750008926 | 1372101 | 1372101 | VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator | LOL | Hepatitis a test (antibody and igm antibody) | 2 | VITROS |
44 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 1 | VITROS |
45 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
46 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
47 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
48 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
49 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
50 | 10758750008742 | 1306026 | 1306026 | VITROS Immunodiagnostic ProductsTestosterone Calibrators | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | VITROS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 30014613337720 | 98202 | 98202 | Triage BNP Calibrators | Triage | QUIDEL CARDIOVASCULAR INC. |
2 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | FastPack® IP SHBG | QUALIGEN INC. |
3 | 15099590750961 | 98202 | 98202 | The Access BNP Calibrators are intended to calibrate the Access BNP test for the The Access BNP Calibrators are intended to calibrate the Access BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems. | Access BNP Calibrators | BECKMAN COULTER, INC. |
4 | 15099590707194 | C26909 | C26909 | The Access hsTnI Calibrators are intended to calibrate the Access hsTnI assay fo The Access hsTnI Calibrators are intended to calibrate the Access hsTnI assay for quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems. | Access hsTnI Calibrators | BECKMAN COULTER, INC. |
5 | 15099590669706 | B23634 | B23634 | Unicel DxC SYNCHRON Systems HDL Calibrator | Synchron | BECKMAN COULTER, INC. |
6 | 15099590666361 | B38859 | Urine CSF Albumin Calibrator | AU | BECKMAN COULTER IRELAND INC. | |
7 | 15099590663421 | A98857 | A98857 | The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Acce The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay for the quantitative determination of total 25-hydroxyvitamin D [25(OH)D] levels in human serum and plasma using the UniCel DxI 800 Immunoassay Systems. | Access 25(OH) Vitamin D Total Calibrators | BECKMAN COULTER, INC. |
8 | 15099590663414 | B24839 | B24839 | The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Acce The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay for the quantitative determination of total 25-hydroxyvitamin D [25(OH)D] levels in human serum and plasma using the Access 2 Immunoassay Systems. Results are to used as an aid in the assessment of vitamin D sufficiency. | Access 25(OH) Vitamin D Total Calibrators | BECKMAN COULTER, INC. |
9 | 15099590233389 | 468405 | 468405 | SYNCHRON Systems CAL 1 Calibrator 1 | Synchron | BECKMAN COULTER, INC. |
10 | 15099590233105 | 442772 | 442772 | SYNCHRON Systems FE/IBCT Calibrator Kit | Synchron | BECKMAN COULTER, INC. |
11 | 15099590232047 | 469170 | 469170 | SYNCHRON Systems APO Calibrator | Synchron | BECKMAN COULTER, INC. |
12 | 15099590231866 | 387647 | 387647 | The Access BR Monitor Calibrators are intended to calibrate the Access BR Monito The Access BR Monitor Calibrators are intended to calibrate the Access BR Monitor assay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems. | Access BR Monitor Calibrators | BECKMAN COULTER, INC. |
13 | 15099590231835 | 387688 | 387688 | The Access GI Monitor Calibrators are intended to calibrate the Access GI Monito The Access GI Monitor Calibrators are intended to calibrate the Access GI Monitor assay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems. | Access GI Monitor Calibrators | BECKMAN COULTER, INC. |
14 | 15099590231699 | 973244 | 973244 | The Access Myoglobin Calibrators are intended to calibrate the Access Myoglobin The Access Myoglobin Calibrators are intended to calibrate the Access Myoglobin assay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. | Access Myoglobin Calibrators | BECKMAN COULTER, INC. |
15 | 15099590231392 | 33545 | 33545 | The Access Estradiol Calibrators are intended to calibrate the Access Estradiol The Access Estradiol Calibrators are intended to calibrate the Access Estradiol assay for the quantitative determination of estradiol levels in human serum and plasma using the Access Immunoassay Systems. | Access Estradiol Calibrators | BECKMAN COULTER, INC. |
16 | 15099590231385 | 33546 | 33546 | The Access Estradiol Calibrator S0 is intended for use with Access Estradiol ass The Access Estradiol Calibrator S0 is intended for use with Access Estradiol assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator | Access Estradiol Calibrator S0 | BECKMAN COULTER, INC. |
17 | 15099590231149 | 33575 | 33575 | The Access Unconjugated Estriol Calibrators are intended to calibrate the Access The Access Unconjugated Estriol Calibrators are intended to calibrate the Access Unconjugated Estriol assay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems. | Access Unconjugated Estriol Calibrators | BECKMAN COULTER, INC. |
18 | 15099590229825 | 445930 | 445930 | SYNCHRON Systems Microprotein Calibrator | Synchron | BECKMAN COULTER, INC. |
19 | 15099590229122 | 387993 | 387993 | The Access Intrinsic Factor Ab Calibrators are intended to calibrate the Access The Access Intrinsic Factor Ab Calibrators are intended to calibrate the Access Intrinsic Factor Ab assay for the detectionof intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. | Access Intrinsic Factor Ab Calibrators | BECKMAN COULTER, INC. |
20 | 15099590223243 | 468429 | 468429 | IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator | IMMAGE | BECKMAN COULTER, INC. |
21 | 15099590209452 | A99250 | A99250 | The Access Folate Calibrator S0 is intended for use with the Access Folate assay The Access Folate Calibrator S0 is intended for use with the Access Folate assay to dilute patient samples containing analyte concentrations greater than the analyte specic S5 calibrator. | Access Folate Calibrator S0 | BECKMAN COULTER, INC. |
22 | 15099590209360 | A98265 | A98265 | The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction. | Access AccuTnI+3 Calibrators | BECKMAN COULTER, INC. |
23 | 15099590209339 | A98144 | A98144 | The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 The Access AccuTnI+3 Calibrators are intended to calibrate the Access AccuTnI+3 Reagent for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 System to aid in the diagnosis of myocardial infarction. | Access AccuTnI+3 Calibrators | BECKMAN COULTER, INC. |
24 | 15099590209315 | A98033 | A98033 | The Access Folate Calibrators are intended to calibrate the Access Folate assay The Access Folate Calibrators are intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin)and red blood cells using the Access Immunoassay Systems. | Access Folate Calibrators | BECKMAN COULTER, INC. |
25 | 15099590204044 | A48618 | A48618 | The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. | Access SHBG Calibrators | BECKMAN COULTER, INC. |
26 | 15099590203122 | A36920 | A36920 | The Access Thyroglobulin Antibody II (TgAb) Calibrators are intended to calibrat The Access Thyroglobulin Antibody II (TgAb) Calibrators are intended to calibrate the Access Thyroglobulin Antibody II assay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. | Access Thyroglobulin Antibody II Calibrators | BECKMAN COULTER, INC. |
27 | 15099590203054 | A36098 | A36098 | The Access Inhibin A Calibrators are intended to calibrate the Access Inhibin A The Access Inhibin A Calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric inhibin A levels in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems. | Access Inhibin A Calibrators | BECKMAN COULTER, INC. |
28 | 15099590202828 | A32494 | A32494 | The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for the quantitative determination of soluable transferrin receptor levels in human serum and plasma (heparin) using the Access Immunoassay Systems. | Access sTfR Calibrators | BECKMAN COULTER, INC. |
29 | 15099590202019 | A18227 | A18227 | The Access TPO Antibody Calibrators are intended to calibrate the Access TPO Ant The Access TPO Antibody Calibrators are intended to calibrate the Access TPO Antibody assay for the quantitative determination of thryoperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems. | Access TPO Antibody Calibrators | BECKMAN COULTER, INC. |
30 | 15099590201920 | A16953 | A16953 | The Access Intact PTH Calibrators are intended to calibrate the Access Intact PT The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. | Access Intact PTH Calibrators | BECKMAN COULTER, INC. |
31 | 15099590201845 | A16365 | A16365 | The Access EPO Calibrators are intended to calibrate the Access EPO assay for th The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems. | Access EPO Calibrators | BECKMAN COULTER, INC. |
32 | 15099590080839 | ODR3029 | Prealbumin Calibrator | AU | BECKMAN COULTER, INC. | |
33 | 15099590070571 | ODC0028 | RF Latex Calibrator | AU | BECKMAN COULTER, INC. | |
34 | 15099590070564 | ODC0027 | CRP Latex Calibrator Highly Sensitive (HS) Set | AU | BECKMAN COULTER, INC. | |
35 | 15099590070557 | ODC0026 | CRP Latex Calibrator Normal (N) Set | AU | BECKMAN COULTER, INC. | |
36 | 15099590070519 | ODC0024 | LDL Cholesterol Calibrator | AU | BECKMAN COULTER, INC. | |
37 | 15099590070502 | ODC0023 | HDL Cholesterol Calibrator | AU | BECKMAN COULTER, INC. | |
38 | 15099590070441 | ODC0019 | BICARBONATE CALIBRATOR | AU | BECKMAN COULTER IRELAND INC. | |
39 | 14987481100999 | 276-76491 | 276-76491 | In-Vitro Diagnostic Use | NEFA Standard Solution | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
40 | 10856626006011 | 276-76491 | 276-76491 | In-Vitro Diagnostic Use | NEFA Standard Solution | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
41 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | FastPack® IP SHBG | QUALIGEN INC. |
42 | 10758750033317 | 6192256 | 6192256 | VITROS Immunodiagnostic Products NT-proBNP II Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
43 | 10758750032051 | 6844424 | 6844424 | VITROS Immunodiagnostic Products C-peptide Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
44 | 10758750032044 | 6844426 | 6844426 | VITROS Immunodiagnostic Products Insulin Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
45 | 10758750030736 | 6842906 | 6842906 | VITROS Chemistry Products Calibrator Kit 31 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
46 | 10758750030200 | 6844055 | 6844055 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
47 | 10758750009213 | 1487289 | 1487289 | VITROS Immunodiagnostic Products TSH Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
48 | 10758750008827 | 1320498 | 1320498 | VITROS Chemistry Products Calibrator Kit 7 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
49 | 10758750008537 | 1204668 | 1204668 | VITROS Chemistry Products Calibrator Kit 4 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
50 | 10758750008445 | 1113596 | 1113596 | VITROS Immunodiagnostic ProductsProlactin Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |