No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04987270230916 | 230916 | JIT | Calibrator, Secondary | 2 | Lumipulse G LH Calibrators | ||
2 | 04987270235058 | 235058 | NTM,PMT,PRI | Antigen, Inflammatory Response Marker, Sepsis,Device To Detect And Measure Proca Antigen, Inflammatory Response Marker, Sepsis,Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens,Procalcitonin Assay | 2 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges | ||
3 | 04987270234440 | 234440 | Soda Lime for LUMIPULSE System | |||||
4 | 04987270234181 | 234181 | JIT | Calibrator, Secondary | 2 | Lumipulse G HE4 Calibrators | ||
5 | 04987270234273 | 234273 | LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | Lumipulse G CA125II Immunoreaction Cartridges | ||
6 | 04987270230688 | 230688 | JIT | Calibrator, Secondary | 2 | Lumipulse G CA125II Calibrators | ||
7 | 04987270226964 | 226964 | PH3000 | KSZ | System, Test, Automated Blood Grouping And Antibody | 2 | Beckman Coulter PK TP System | |
8 | 04987270235171 | 235171 | CHP | Radioimmunoassay, Estradiol | 1 | Lumipulse G E2-III Immunoreaction Cartridges | ||
9 | 04987270231197 | 231197 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Lumipulse G Substrate Solution | ||
10 | 04987270230893 | 230893 | JIT | Calibrator, Secondary | 2 | Lumipulse G Progesterone-N Calibrators | ||
11 | 04987270230466 | 230466 | Lumipulse G Dilution Cartridges | |||||
12 | 04987270230206 | 230206 | Lumipulse G Whole PTH Calibrators | |||||
13 | 04987270231135 | 231135 | JIT | Calibrator, Secondary | 2 | Lumipulse G TSH-III Calibrators | ||
14 | 04987270235294 | 235294 | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | Lumipulse G TSH-III Immunoreaction Cartridges | ||
15 | 04987270235218 | 235218 | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | Lumipulse G FSH-N Immunoreaction Cartridges | ||
16 | 04987270234020 | 234020 | JIT | Calibrator, Secondary | 2 | Lumipulse G 25-OH Vitamin D Calibrators | ||
17 | 04987270230664 | 230664 | Lumipulse G CA 19-9-N Calibrators | |||||
18 | 04987270235256 | 235256 | JLS | Radioimmunoassay, Progesterone | 1 | Lumipulse G Progesterone-N Immunoreaction Cartridges | ||
19 | 04987270230985 | 230985 | GIF | Diluent, Blood Cell | 1 | Lumipulse G Specimen Diluent 2 | ||
20 | 04987270235195 | 235195 | CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | Lumipulse G Prolactin Immunoreaction Cartridges | ||
21 | 04987270235126 | 235126 | Lumipulse G CA 19-9-N Immunoreaction Cartridges | |||||
22 | 04987270235089 | 235089 | MRG | System, Test, Vitamin D | 2 | Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges | ||
23 | 04987270234259 | 234259 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | LUMIPULSE G1200 | ||
24 | 04987270231203 | 231203 | GIF | Diluent, Blood Cell | 1 | Lumipulse G Specimen Diluent 1 | ||
25 | 04987270230954 | 230954 | JIT | Calibrator, Secondary | 2 | Lumipulse G Prolactin Calibrators | ||
26 | 04987270231173 | 231173 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Lumipulse G Wash Solution | ||
27 | 04987270235270 | 235270 | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | Lumipulse G LH Immunoreaction Cartridges | ||
28 | 04987270234174 | 234174 | OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | 2 | Lumipulse G HE4 Immunoreaction Cartridges | ||
29 | 04987270234167 | 234167 | NTM,PMT,PRI | Antigen, Inflammatory Response Marker, Sepsis,Device To Detect And Measure Proca Antigen, Inflammatory Response Marker, Sepsis,Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens,Procalcitonin Assay | 2 | Lumipulse BRAHMS PCT Controls | ||
30 | 04987270233849 | 233849 | JIT | Calibrator, Secondary | 2 | Lumipulse G E2-III Calibrators | ||
31 | 04987270230930 | 230930 | JIT | Calibrator, Secondary | 2 | Lumipulse G FSH-N Calibrators | ||
32 | 04987270230879 | 230879 | GIF | Diluent, Blood Cell | 1 | Lumipulse G Specimen Diluent 3 | ||
33 | 04987270227541 | 227541 | PA2300 | KSZ | System, Test, Automated Blood Grouping And Antibody | 2 | Beckman Coulter PK CMV-PA System | |
34 | 04987270234693 | 234693 | GIF | Diluent, Blood Cell | 1 | Lumipulse G Specimen Diluent 6 | ||
35 | 04987270234150 | 234150 | JIT | Calibrator, Secondary | 2 | Lumipulse G BRAHMS PCT Calibrator Set | ||
36 | 04987270230213 | 230213 | Lumipulse PTH Controls | |||||
37 | 04987270230190 | 230190 | Lumipulse G whole PTH Immunoreaction Cartridges |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00630414976891 | 10471981 | L2KSY2(D) | Syphilis - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems SYP Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
2 | 00630414976709 | 10469595 | LCVGCM | CMV IgG - IMMULITE - CTL | IMMULITE® Systems CVG CONTROL CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
3 | 00630414976686 | 10469593 | LSYCM | Syphillis - IMMULITE - CTL - 2x6mL | IMMULITE® Systems SYP CONTROL Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
4 | 00630414599892 | 10995676 | 10995676 | Syphillis (Syph) QC Kit Atellica IM - CLT 2 x 2 x 7.0mL | Atellica IM Syph QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414599885 | 10995675 | 10995675 | Syphillis (Syph) Atellica IM - RGT 200T | Atellica IM Syph | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414580173 | 10492493 | 10492493 | Syphilis - CENTAUR - RGT - 200 tests | ADVIA Centaur® SYPH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00607158000083 | 65-9502-0 | The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection. | DPP HIV-Syphilis | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
8 | 00380740138332 | 07P6031 | 07P6031 | Alinity i Syphilis TP Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
9 | 00380740138196 | 07P6021 | 07P6021 | Alinity i Syphilis TP Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
10 | 00380740117122 | 8D06-41 | 08D0641 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
11 | 00380740117115 | 8D06-31 | 08D0631 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
12 | 00380740103545 | 8D06-13 | 08D0613 | ARCHITECT Syphilis TP Controls | ARCHITECT | ABBOTT GMBH |
13 | 00380740103538 | 8D06-04 | 08D0604 | ARCHITECT Syphilis TP Calibrator | ARCHITECT | ABBOTT GMBH |
14 | 07613336171998 | 09015051190 | 09015051190 | Syphilis Elecsys E2G 300 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
15 | 07613336171950 | 09014977190 | 09014977190 | Syphilis Elecsys cobas e 100 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
16 | 05391516748766 | 1206711 | 1206711 | Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Positive Control and 1 Negative Control | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
17 | 05391516748759 | 1206710 | 1206710 | Uni-Gold™ Syphilis Treponemal, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
18 | 05391516747462 | TS-96-E | TS-96-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
19 | 05391516747448 | TS-960-E | TS-960-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
20 | 05391516747431 | TS-960 | TS-960 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
21 | 05391516747424 | TS-96-Bulk | Trep Sure Bulk Kit | Phoenix Biotech | CLARK LABORATORIES, INC. | |
22 | 05391516747417 | TS-96 | TS-96 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
23 | 05391516747400 | TS-1920 | TS-1920 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
24 | 05391516747226 | 916401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
25 | 05391516746915 | 386470 | 386470 | Trep-Sure Conjugate | Phoenix Biotech | CLARK LABORATORIES, INC. |
26 | 05391516746908 | 829322 | Wash Buffer Concentrate 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
27 | 05391516746892 | 828882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
28 | 05391516746861 | 827882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
29 | 05391516746847 | 525777 | 525777 | Trep-Sure Substrate | Phoenix Biotech | CLARK LABORATORIES, INC. |
30 | 05391516746694 | 72520 | 72520 | Syphilis IgM EIA | BIO-RAD | CLARK LABORATORIES, INC. |
31 | 05391516746687 | 72517 | 72517 | Wash Solution, x20 (Non US Sales Only) | Bio-Rad | CLARK LABORATORIES, INC. |
32 | 05391516746588 | YY60126 | Syphilis EIA (Non-US sales only) | Bio-Stat | CLARK LABORATORIES, INC. | |
33 | 05391516745109 | 2322171 | 2322171 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
34 | 05391516745093 | 2322170 | 2322170 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
35 | 05391516745048 | 2329360 | 2329360 | CAPTIA™ NMT Syphilis IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
36 | 05391516744836 | 800-960 | 800-960 | CAPTIA™ Syphilis (T. Pallidum)-G | Trinity Biotech | CLARK LABORATORIES, INC. |
37 | 05391516744829 | 800-970 | 800-970 | CAPTIA™Syphilis (T. Pallidum)-G | Trinity Biotech | CLARK LABORATORIES, INC. |
38 | 04987270235041 | 235041 | Lumipulse G TP-N Immunoreaction Cartridges Set | FUJIREBIO INC. | ||
39 | 04015630940356 | 07251378190 | 07251378190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
40 | 04015630934881 | 06923348190 | 06923348190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
41 | 03610522015597 | 12007240 | 12007240 | U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
42 | 03610522004980 | 12006863 | 12006863 | BioPlex 2200 Sample Dilution Buffer (1X), 120 mL | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
43 | 03610520992692 | 4.3 | 12000656 | U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
44 | 03610520653012 | 12000650 | 12000650 | BioPlex 2200 Syphilis Total & RPR Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
45 | 03610520138267 | 4.3_v1 | 12000657 | BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
46 | 00868926000302 | B012 | Syphilis Health Check | VEDALAB | ||
47 | 00850487007609 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
48 | 00850487007043 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
49 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |