| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08809301168073 | GT-C03 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 3 | ||
| 2 | 08809301161029 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
| 3 | 08809301160411 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate Smart Blood Glucose Monitoring System | ||
| 4 | 08809301162194 | PC001-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Low | ||
| 5 | 08809301162200 | PC002-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Normal | ||
| 6 | 08809301161036 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
| 7 | 08809301162026 | PC-003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 3 | ||
| 8 | 08809301161760 | PS-004 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Pip Blood Glucose Test Strips | |||
| 9 | 08809301168059 | GT-C01 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 1 | ||
| 10 | 08809301160152 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
| 11 | 08809301160114 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
| 12 | 08809301160015 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
| 13 | 08809301160862 | PG-310 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | Pip Blood Glucose Monitoring System | ||
| 14 | 08809301160213 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
| 15 | 08809301160138 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
| 16 | 08809301160084 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
| 17 | 08809301168066 | GT-C02 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 2 | ||
| 18 | 08809301168134 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
| 19 | 08809301168127 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
| 20 | 08809301168110 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
| 21 | 08809301162057 | PC-001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 1 | ||
| 22 | 08809301168042 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
| 23 | 08809301168011 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
| 24 | 08809301160206 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
| 25 | 08809301160145 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
| 26 | 08809301160077 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
| 27 | 08809301168103 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
| 28 | 08809301168097 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
| 29 | 08809301168080 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack Voice Blood Glucose Monitoring System | ||
| 30 | 08809301166031 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
| 31 | 08809301166017 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
| 32 | 08809301166000 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
| 33 | 08809301162217 | PC003-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution High | ||
| 34 | 08809301160169 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
| 35 | 08809301160121 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
| 36 | 08809301160022 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System |
| 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 |