No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05060169693906 | IS-IM100 | IDS Immunocleaner | |||||
2 | 05060169690165 | AC-04F1 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | Alpha CrossLaps® (CTX-I) EIA | ||
3 | 05060169695962 | IS-ID6502 | QKO | Reagent, Coronavirus Serological | IDS SARS-COV-2 IgG | |||
4 | 05060169695801 | IS-2800US | CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 | IDS-iSYS Ostase® BAP | ||
5 | 05060169691339 | IS-5630 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS SHBG Control Set | ||
6 | 05060169690950 | IS-3235 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Intact PTH Calibration Verifiers | ||
7 | 05060169690424 | IS-2735S | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers | ||
8 | 05060169690417 | IS-2730S | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25-Hydroxy Vitamin DS Control Set | ||
9 | 05060169690400 | IS-2700S | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 25-Hydroxy Vitamin DS | ||
10 | 05060169690288 | IS-3900 | OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | 1 | IDS-iSYS Insulin like Growth Factor-1 (IGF-1) | ||
11 | 05060169693517 | IS-2200 | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | IDS-iSYS Intact PTHN | ||
12 | 05060169690943 | IS-3035 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers | ||
13 | 05060169690929 | IS-2535 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25 VitDS Calibration Verifiers | ||
14 | 05060169690912 | IS-2435 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 1,25-Dihydroxy Vitamin D Calibration Verifiers | ||
15 | 05060169690370 | IS-3330 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Aldosterone Control Set | ||
16 | 05060169690349 | IS-2400 | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 1,25-Dihydroxy Vitamin D | ||
17 | 05060169690059 | AC-20F1 | CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 | Ostase®+ BAP EIA | ||
18 | 05060169690028 | AA-54F2 | MRG | System, Test, Vitamin D | 2 | 1,25 Dihydroxy Vitamin D RIA | ||
19 | 05060169690011 | AA-54F1 | MRG | System, Test, Vitamin D | 2 | 1,25 Dihydroxy Vitamin D RIA | ||
20 | 05060169695818 | IS-2830US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Ostase® BAP Control Set | ||
21 | 05060169691124 | CQ-Seal | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | ImCap Seal | ||
22 | 05060169691094 | IS-10DA | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | IDS-iSYS Diluent A | ||
23 | 05060169690455 | AC-57SF1 | MRG | System, Test, Vitamin D | 2 | 25-Hydroxy Vitamin Ds EIA | ||
24 | 05060169690363 | IS-3300 | CJM | Radioimmunoassay, Aldosterone | 2 | IDS-iSYS Aldosterone | ||
25 | 05060169690295 | IS-3930 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Insulin like Growth Factor-1 (IGF-I) Control Set | ||
26 | 05060169690271 | IS-3230 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Intact PTH Control Set | ||
27 | 05060169690240 | IS-3000 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | IDS-iSYS CTX-I (Crosslaps) | ||
28 | 05060169695979 | IS-ID6530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS SARS-COV-2 IgG Control Set | ||
29 | 05060169695825 | IS-2835US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Ostase® BAP Calibration Verifiers | ||
30 | 05060169690691 | IS-4600 | CGR | Radioimmunoassay, Cortisol | 2 | IDS Cortisol | ||
31 | 05060169690516 | AC-11F1 | NEO | System, Test, Osteocalcin | 2 | N-MID® Osteocalcin ELISA | ||
32 | 05060169695504 | IS-4620 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS Cortisol Calibrator Set | ||
33 | 05060169691322 | IS-5600 | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | IDS SHBG | ||
34 | 05060169690318 | IS-4430 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set | ||
35 | 05060169690301 | IS-4400 | CFL | Radioimmunoassay, Human Growth Hormone | 1 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) | ||
36 | 05060169690158 | AC-05F1 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | Urine BETA CrossLaps® (CTX-I) ELISA | ||
37 | 05060169695306 | IS-2530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25 VitDS Control Set | ||
38 | 05060169690974 | IS-3735 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers | ||
39 | 05060169690851 | IS-4830 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Direct Renin Control Set | ||
40 | 05060169690820 | IS-4630 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS Cortisol Control Set | ||
41 | 05060169690752 | IS-2530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25 VitDS Control Set | ||
42 | 05060169690257 | IS-3030 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS CTX-I (Crosslaps) Control Set | ||
43 | 05060169690172 | AC-10F1 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | Urine CartiLaps ® (CTX-II) EIA | ||
44 | 05060169690097 | AC-62F1 | MRG | System, Test, Vitamin D | 2 | 1,25-Dihydroxy Vitamin D EIA | ||
45 | 05060169690004 | AA-35F1 | MRG | System, Test, Vitamin D | 2 | 25-Hydroxy Vitamin D RIA | ||
46 | 05060169695320 | IS-2520N | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 25 VitDS Calibrator Set | ||
47 | 05060169695283 | IS-2500N | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 25 VitDS | ||
48 | 05060169693708 | IS-5635 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS SHBG Calibration Verifiers | ||
49 | 05060169691223 | IS-310400 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | IDS-iSYS Multi Discipline Automated System | ||
50 | 05060169691117 | CQ-FULL | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | ImCap Rack |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15430001412137 | 1 | In vitro transcript of Mycoplasma genitalium 23S RNA | Mycoplama genitalium IVT Wild type control | DIAGENODE | |
2 | 15430001412120 | 1 | PRD-06113 | In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation | Mycoplasma genitamium macrolide resistance IVT A 2059G control | DIAGENODE |
3 | 15430001412113 | 1 | In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation | Mycoplasma genitalium macrolide resistance IVT A2059C Control | DIAGENODE | |
4 | 15430001412106 | 1 | PRD-06111 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058T mutation | Mycoplasma genitalium macrolide resistance IVT A2058T Controls | DIAGENODE |
5 | 15430001412090 | 1 | PRD-06110 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation | Mycoplasma genitalium macrolide resistance IVT A2058G Control | DIAGENODE |
6 | 15430001412083 | 1 | PRD-06109 | In vitro transcript of Mycoplasma genitalium 23S RNA including A2058C mutation | Mycoplasma genitalium Macrolide Resistance IVT A2058C Control | DIAGENODE |
7 | 15420045509382 | CLASS I CONTROL - C. GLABRATA | PRD-04522 | Aptima | HOLOGIC, INC. | |
8 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | aptima | HOLOGIC, INC. | |
9 | 15420045509368 | CLASS I CONTROL - G. VAGINALIS | PRD-04520 | Aptima | HOLOGIC, INC. | |
10 | 15420045509351 | CLASS I CONTROL - L. CRISPATUS | PRD-04519 | Aptima | HOLOGIC, INC. | |
11 | 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. |
12 | 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. |
13 | 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. |
14 | 15099590232108 | 650038 | 650038 | Vigil HbA1c Controls Levels 1 & 2 | Vigil | BECKMAN COULTER, INC. |
15 | 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. |
16 | 15099590228705 | 667710 | 667710 | Ultimate -D Bilirubin Control Level 1 | Ultimate | BECKMAN COULTER, INC. |
17 | 15099590223038 | 667720 | 667720 | Ultimate -D Bilirubin Control Level 2 | Ultimate | BECKMAN COULTER, INC. |
18 | 15099590223021 | 667730 | 667730 | Ultimate -D Bilirubin Control Level 3 | Ultimate | BECKMAN COULTER, INC. |
19 | 15099590223014 | 667740 | 667740 | Ultimate -D Bilirubin Control Level 4 | Ultimate | BECKMAN COULTER, INC. |
20 | 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. |
21 | 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. |
22 | 15099590204051 | A48619 | A48619 | The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay. | Access SHBG QC | BECKMAN COULTER, INC. |
23 | 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. |
24 | 14987481164496 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | uTASWako DCP Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
25 | 14987481164489 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | uTASWako DCP Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
26 | 14987481164458 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
27 | 14987481164441 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
28 | 10888277675698 | MPH6560 | MPH6560 | CONTROL, HARMONY HI LO | Medline | MEDLINE INDUSTRIES, INC. |
29 | 10859952006014 | A40400 | Di Description | Brand name | LIFE TECHNOLOGIES CORPORATION | |
30 | 10856626006172 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
31 | 10856626006134 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | uTASWako DCP Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
32 | 10856626006073 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
33 | 10856626006066 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | uTASWako DCP Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
34 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | FastPack® IP SHBG | QUALIGEN INC. |
35 | 10763924550507 | MD550 | Lipid and Glucose Measuring System | LipidPlus® Meter | JANT PHARMACAL CORPORATION | |
36 | 10758750030163 | 6842957 | 6842957 | VITROS Chemistry Products HCY 2 Performance Verifier I, II, III | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
37 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
38 | 10758750006953 | 6801747 | 6801747 | VITROS Chemistry Products mALB Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
39 | 10758750006946 | 6801746 | 6801746 | VITROS Chemistry Products mALB Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
40 | 10758750006243 | 6802894 | 6802894 | VITROS Immunodiagnostic Products Intact PTH Range Verifier | VITROS | ORTHO CLINICAL DIAGNOSTICS |
41 | 10758750006236 | 6802895 | 6802895 | VITROS Immunodiagnostic Products Intact PTH Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
42 | 10758750002573 | 6802313 | 6802313 | VITROS Chemistry Products AAT/HPT Performance Verifier III | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
43 | 10758750002566 | 6802312 | 6802312 | VITROS Chemistry Products AAT/HPT Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
44 | 10758750002559 | 6802311 | 6802311 | VITROS Chemistry Products AAT/HPT Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
45 | 10758750002528 | 6802303 | 6802303 | VITROS Immunodiagnostic Products Troponin I ES Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
46 | 10758750002368 | 6802242 | 6802242 | VITROS Immunodiagnostic Products CA 19-9™ Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
47 | 10758750002344 | 6802222 | 6802222 | VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
48 | 10758750002085 | 6802158 | 6802158 | VITROS Immunodiagnostic Products NT-proBNP Range Verifiers | VITROS | ORTHO CLINICAL DIAGNOSTICS |
49 | 10758750001972 | 6802093 | 6802093 | VITROS Immunodiagnostic Products Anti-HBs Quantitative Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
50 | 10758750001545 | 6801863 | 6801863 | VITROS Immunodiagnostic Products Anti-HIV 1 + 2 Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |