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 | 10758750009213 | 1487289 | 1487289 | VITROS Immunodiagnostic Products TSH Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
37 | 10758750009145 | 1471481 | 1471481 | VITROS Immunodiagnostic Products T3 Uptake Reagent Pack | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | 2 | VITROS |
38 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
39 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | VITROS |
40 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
41 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
42 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
43 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | CEC | RADIOIMMUNOASSAY, FREE THYROXINE | 2 | VITROS |
44 | 10758750008926 | 1372101 | 1372101 | VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator | LOL | Hepatitis a test (antibody and igm antibody) | 2 | VITROS |
45 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 1 | VITROS |
46 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
47 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
48 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
49 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
50 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 30014613337713 | 98201 | 98201 | Triage BNP QC Controls | Triage | QUIDEL CARDIOVASCULAR INC. |
2 | 30014613337072 | 98814EU | 98814EU | Triage PLGF Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
3 | 30014613337065 | 98813EU | 98813EU | Triage PLGF Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
4 | 30014613337058 | 98714EU | 98714EU | Triage NT-proBNP Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
5 | 30014613337041 | 98713EU | 98713EU | Triage NT-proBNP Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
6 | 30014613337034 | 98015XR | 98015XR | Quidel Triage® BNP Calibration Verification | Triage | QUIDEL CARDIOVASCULAR INC. |
7 | 30014613337027 | 98014XR | 98014XR | Quidel Triage® BNP Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
8 | 30014613337010 | 98013XR | 98013XR | Triage BNP Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
9 | 30014613336747 | RPS-ID-20 | RPS-ID-20 | InflammaDry | InflammaDry | QUIDEL CORPORATION |
10 | 30014613311195 | M119 | M119 | QMol Trichomonas Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
11 | 30014613311171 | M117 | M117 | QMol Bordetella Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
12 | 30014613311164 | M116 | M116 | QMol GBS Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
13 | 30014613311157 | M115 | M115 | QMol Parainflu Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
14 | 30014613311102 | M110 | M110 | QMol Adeno Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
15 | 30014613311089 | M108 | M108 | QMol CDIFF Control Set | Quidel Molecular | DIAGNOSTIC HYBRIDS, INC. |
16 | 30014613002819 | 00281 | 00281 | hCG Ctrl Set - Serum | QuickVue | QUIDEL CORPORATION |
17 | 30014613002727 | 00272 | 00272 | hCG Ctrl Set - Urine | QuickVue | QUIDEL CORPORATION |
18 | MHC18490112 | 849011 | BluLink Test Strips 50ct | BluLink | MHC MEDICAL PRODUCTS, LLC | |
19 | MHC18100012 | 810001 | EasyTouch | MHC MEDICAL PRODUCTS, LLC | ||
20 | MHC18090112 | 809011 | HealthPro | MHC MEDICAL PRODUCTS, LLC | ||
21 | 20885380020275 | B1077-24 | B1077-24 | hCG Controls; 1 Set; IVD | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
22 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | FastPack® IP SHBG | QUALIGEN INC. |
23 | 15430001412137 | 1 | In vitro transcript of Mycoplasma genitalium 23S RNA | Mycoplama genitalium IVT Wild type control | DIAGENODE | |
24 | 15430001412120 | 1 | PRD-06113 | In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation | Mycoplasma genitamium macrolide resistance IVT A 2059G control | DIAGENODE |
25 | 15430001412113 | 1 | In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation | Mycoplasma genitalium macrolide resistance IVT A2059C Control | DIAGENODE | |
26 | 15430001412106 | 1 | PRD-06111 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058T mutation | Mycoplasma genitalium macrolide resistance IVT A2058T Controls | DIAGENODE |
27 | 15430001412090 | 1 | PRD-06110 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation | Mycoplasma genitalium macrolide resistance IVT A2058G Control | DIAGENODE |
28 | 15430001412083 | 1 | PRD-06109 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058C mutation | Mycoplasma genitalium Macrolide Resistance IVT A2058C Control | DIAGENODE |
29 | 15420045509382 | CLASS I CONTROL - C. GLABRATA | PRD-04522 | Aptima | HOLOGIC, INC. | |
30 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | aptima | HOLOGIC, INC. | |
31 | 15420045509368 | CLASS I CONTROL - G. VAGINALIS | PRD-04520 | Aptima | HOLOGIC, INC. | |
32 | 15420045509351 | CLASS I CONTROL - L. CRISPATUS | PRD-04519 | Aptima | HOLOGIC, INC. | |
33 | 15099590750954 | 98201 | 98201 | The Access BNP QC Controls are intended for monitoring the performance of the Ac The Access BNP QC Controls are intended for monitoring the performance of the Access BNP test using the Beckman Coulter Access Family of Immunoassay Systems. | Access BNP QC | BECKMAN COULTER, INC. |
34 | 15099590677398 | B83877 | B83877 | The Access Ostase QC is intended for monitoring system performance of the Access The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | Access Ostase QC | BECKMAN COULTER, INC. |
35 | 15099590232290 | 37309 | 37309 | The Access Ostase QC is intended for monitoring system performance of the Access The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | Access Ostase QC | BECKMAN COULTER, INC. |
36 | 15099590232108 | 650038 | 650038 | Vigil HbA1c Controls Levels 1 & 2 | Vigil | BECKMAN COULTER, INC. |
37 | 15099590229108 | 387999 | 387999 | The Access Intrinsic Factor Ab QC is intended for monitoring system performance The Access Intrinsic Factor Ab QC is intended for monitoring system performance of the Access Intrinsic Factor Ab assay. | Access Intrinsic Factor Ab QC | BECKMAN COULTER, INC. |
38 | 15099590228705 | 667710 | 667710 | Ultimate -D Bilirubin Control Level 1 | Ultimate | BECKMAN COULTER, INC. |
39 | 15099590223038 | 667720 | 667720 | Ultimate -D Bilirubin Control Level 2 | Ultimate | BECKMAN COULTER, INC. |
40 | 15099590223021 | 667730 | 667730 | Ultimate -D Bilirubin Control Level 3 | Ultimate | BECKMAN COULTER, INC. |
41 | 15099590223014 | 667740 | 667740 | Ultimate -D Bilirubin Control Level 4 | Ultimate | BECKMAN COULTER, INC. |
42 | 15099590210717 | B11057 | B11057 | The Access sTfR QC2 and QC3 is intended for monitoring system performance of the The Access sTfR QC2 and QC3 is intended for monitoring system performance of the Access sTfR assay. | Access sTfR QC2 and QC3 | BECKMAN COULTER, INC. |
43 | 15099590210700 | B11056 | B11056 | The Access sTfR QC1 is intended for monitoring system performance of the Access The Access sTfR QC1 is intended for monitoring system performance of the Access sTfR assay. | Access sTfR QC1 | BECKMAN COULTER, INC. |
44 | 15099590204051 | A48619 | A48619 | The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay. | Access SHBG QC | BECKMAN COULTER, INC. |
45 | 15099590203061 | A36100 | A36100 | The Access Inhibin A QC is intended for monitoring system performance of the Acc The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay. | Access Inhibin A QC | BECKMAN COULTER, INC. |
46 | 14987481164496 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | uTASWako DCP Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
47 | 14987481164489 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | uTASWako DCP Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
48 | 14987481164458 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
49 | 14987481164441 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
50 | 10888277675698 | MPH6560 | MPH6560 | CONTROL, HARMONY HI LO | Medline | MEDLINE INDUSTRIES, INC. |