No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05391516747226 | 916401 | Stop Solution | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
2 | 05391516747134 | 41-9002 | B. burgdorferi Marsorb | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech | |
3 | 05391516743433 | 2325300 | 2325300 | Captia™ Rubella IgG | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
4 | 05391516747127 | 2326001 | 2326001 | Captia™ Measles IgG | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Trinity Biotech |
5 | 05391516747455 | 4384240 | System Verify Dye Test for automated analyzers | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | Trinity Biotech | |
6 | 05391516747486 | 2346581 | 2346581 | Captia Borrelia burgdorferi IgG/IgM | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
7 | 05391516747547 | 40-1013 | 40-1013 | B. burgdorferi Wash Buffer (10x) | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
8 | 05391516747516 | 2346401 | 2346401 | Captia H. pylori IgG | LYR | Helicobacter Pylori | 1 | Trinity Biotech |
9 | 05391516747479 | 618739 | Serum Diluent Plus | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech | |
10 | 05391516747240 | A7040 | A7040 | ACE CONTROL-E | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Trinity Biotech |
11 | 05391516747233 | A6040 | A6040 | ACE CONTROL-N | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Trinity Biotech |
12 | 05391516747202 | 2346980 | 2346980 | Captia™ Legionella pneumophila IgG/IgM | MJH | Legionella, Spp., Elisa | 2 | Trinity Biotech |
13 | 05391516747189 | 2346580 | 2346580 | Captia™ Borrelia burgdorferi IgG/IgM | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
14 | 05391516747172 | 2338571 | 2338571 | Captia™ ENA Combined Screen | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Trinity Biotech |
15 | 05391516747165 | 2337770 | 2337770 | Captia™ Histone | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | Trinity Biotech |
16 | 05391516747158 | 2328250 | 2328250 | Captia™ Rheumatoid Factor IgM | DHR | System, Test, Rheumatoid Factor | 2 | Trinity Biotech |
17 | 05391516747141 | 2327671 | 2327671 | Captia™ ds/DNA | LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | Trinity Biotech |
18 | 05391516747066 | 2325601 | 2325601 | Captia™ Varicella-Zoster Virus (VZV) IgG | GQX | Antiserum, Cf, Varicella-Zoster | 2 | Trinity Biotech |
19 | 05391516747059 | 2325561 | 2325561 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgM | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | Trinity Biotech |
20 | 05391516747042 | 2325501 | 2325501 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgG | GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | Trinity Biotech |
21 | 05391516747035 | 2325461 | 2325461 | Captia™ Herpes Simplex Virus 1 (HSV 1) IgM | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | Trinity Biotech |
22 | 05391516747028 | 2325401 | 2325401 | Captia™ Herpes Simplex Virus 1 (HSV1) IgG | GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | Trinity Biotech |
23 | 05391516747011 | 2325361 | 2325361 | Captia™ Rubella IgM | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
24 | 05391516747004 | 2325301 | 2325301 | Captia™ Rubella IgG | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
25 | 05391516746991 | 2325261 | 2325261 | Captia™ Cytomegalovirus (CMV) IgM | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech |
26 | 05391516746984 | 2325201 | 2325201 | Captia™ Cytomegalovirus (CMV) IgG | GQI | Antiserum, Cf, Cytomegalovirus | 2 | Trinity Biotech |
27 | 05391516746977 | 2325161 | 2325161 | Captia™ Toxoplasma gondii IgM | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech |
28 | 05391516746960 | 2325101 | 2325101 | Captia™ Toxoplasma gondii IgG | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech |
29 | 05391516746953 | 2325001 | 2325001 | Captia™ EBV EA-D IgG | LSE | Epstein-Barr Virus, Other | 1 | Trinity Biotech |
30 | 05391516746946 | 2324701 | 2324701 | Captia™ EBV VCA P-18 IgG | LSE | Epstein-Barr Virus, Other | 1 | Trinity Biotech |
31 | 05391516746939 | 2323901 | 2323901 | Captia™ HSV 2 Type Specific IgG | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | Trinity Biotech |
32 | 05391516746922 | 2323801 | 2323801 | Captia™ HSV 1 Type Specific IgG | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | Trinity Biotech |
33 | 05391516746908 | 829322 | Wash Buffer Concentrate 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
34 | 05391516746892 | 828882 | Trep-Sure Wash Buffer Concentrate, 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
35 | 05391516746885 | 828322 | Wash Buffer Concentrate 20X | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech | |
36 | 05391516746878 | 828102 | Wash Buffer Concentrate Type I, 20X | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
37 | 05391516746861 | 827882 | Trep-Sure Wash Buffer Concentrate, 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
38 | 05391516746854 | 827402 | Wash Buffer Concentrate Type II, 20X | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Trinity Biotech | |
39 | 05391516746533 | 525700 | Substrate Solution (TMB) | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
40 | 05391516746526 | 915401 | Stop Solution | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
41 | 05391516746519 | 827102 | Wash Buffer Concentrate Type I, 20X | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
42 | 05391516746496 | 2346600 | 2346600 | Captia™ Herpes Group IgG | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Trinity Biotech |
43 | 05391516746489 | 2326660 | 2326660 | Captia™ Herpes Simplex Virus (HSV) Combined IgM | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Trinity Biotech |
44 | 05391516745147 | 2622471 | 2622471 | Captia™ Malaria EIA | OAX | Plasmodium Spp. Detection Reagents | 2 | Trinity Biotech |
45 | 05391516745130 | 2322471 | 2322471 | CAPTIA™ Malaria EIA | OAX | Plasmodium Spp. Detection Reagents | 2 | Trinity Biotech |
46 | 05391516744836 | 800-960 | 800-960 | CAPTIA™ Syphilis (T. Pallidum)-G | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
47 | 05391516744829 | 800-970 | 800-970 | CAPTIA™Syphilis (T. Pallidum)-G | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
48 | 05391516744065 | B1029-440 | B1029-440 | Bartels ELISA Legionella Urinary Antigen | MJH | Legionella, Spp., Elisa | 2 | Trinity Biotech |
49 | 05391516743952 | 2346200 | 2346200 | Captia™ Chlamydia IgG | LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | Trinity Biotech |
50 | 05391516743945 | 2344800 | 2344800 | Captia Mycoplasma IgG | LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 1 | Trinity Biotech |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00630414963822 | 10381289 | LKCV1 | CMV IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
2 | 00630414961231 | 10381309 | L2KCVG2 | CMV IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems CVG CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
3 | 00630414588872 | 10632820 | 10632820 | CMV IgG ADVIA Centaur - RGT - 100T | ADVIA Centaur CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
4 | 00630414246635 | 11202208 | 11202208 | CMV IgG Atellica IM - RGT - 100T | Atellica IM CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | B3507203200 | 720-320 | 720-320 | ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytome ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals. | Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
6 | 05391516747219 | 800-945 | 800-945 | Captia™ Cytomegalovirus IgM Capture | Trinity Biotech | CLARK LABORATORIES, INC. |
7 | 05391516746991 | 2325261 | 2325261 | Captia™ Cytomegalovirus (CMV) IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
8 | 05391516746885 | 828322 | Wash Buffer Concentrate 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
9 | 05391516745031 | 2322671 | 2322671 | CAPTIA™ CMV TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
10 | 05391516745024 | 2322670 | 2322670 | CAPTIA™ CMV TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
11 | 05391516743426 | 2325260 | 2325260 | Captia™ Cytomegalovirus IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
12 | 05391516743419 | 2325250 | 2325250 | Captia™ Cytomegalovirus IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
13 | 04015630940189 | 07027133190 | 07027133190 | Elecsys CMV IgM | ROCHE DIAGNOSTICS GMBH | |
14 | 04015630940172 | 07027117190 | 07027117190 | Elecsys CMV IgG | ROCHE DIAGNOSTICS GMBH | |
15 | 04015630938926 | 4784618160 | 4784618160 | Elecsys CMV IgM Immunoassay | ROCHE DIAGNOSTICS GMBH | |
16 | 04015630937172 | 7309325160 | 7309325160 | Elecsys CMV IgG Assay | ROCHE DIAGNOSTICS GMBH | |
17 | 03610521167488 | 4.3_v1 | 12005791 | U.S. IFU, Manual & CDs, BioPlex 2200 ToRC IgM IFU SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
18 | 03610520992715 | 12000670 | 12000670 | BioPlex 2200 ToRC IgM Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
19 | 03610520150269 | 4.3_v1 | 12000671 | BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
20 | 03573026156831 | 30204-01 | VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of CMV IgG concentration in human serum or plasma. | VIDAS® CMV IgG | BIOMERIEUX SA | |
21 | 00894175000558 | DACD 1202-2 | 1202-2 | AccuDiag™ Cytomegalovirus IgM ELISAA collection of reagents and other associated AccuDiag™ Cytomegalovirus IgM ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen, using an enzyme immunoassay (EIA) method. | AccuDiag™ | DIAGNOSTIC AUTOMATION, INC. |
22 | 00894175000053 | DACD 1201-2 | 1201-2 | AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (E AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV. | AccuDiag ™ | DIAGNOSTIC AUTOMATION, INC. |
23 | 00850487007326 | CMV M | Q01-150 | Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
24 | 00850487007319 | CMV G | Q01-140 | Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoa Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
25 | 00850487007210 | CMV G | Q01-140 | Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoa Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
26 | 00850487007203 | CMV M | Q01-150 | Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
27 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
28 | 00847865011198 | 25192 | 25192 | Substrate for Serology EIA Tests | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
29 | 00847865011181 | 25191 | 25191 | Stop Reagent for Serology EIA Tests | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
30 | 00847865011174 | 25190 | 25190 | Wash Concentrate for Serology EIA Tests | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
31 | 00847865011150 | 25188 | 25188 | Diluent for Rubella IgM, CMV IgM and VCA IgM EIA Tests | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
32 | 00847865011136 | 25186 | 25186 | Diluent for Rubella, Toxo, CMV, HSV, VZV, Measles, Mumps, EBNA and EB EAD IgG EIA Tests | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
33 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
34 | 00847865010733 | 25178 | 25178 | CMV IgM EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
35 | 00847865010726 | 25177 | 25177 | CMV IgG EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
36 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
37 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
38 | 00847865001175 | 6653850 | 6653850 | Rubella & CMV IgM Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
39 | 00817273020150 | 720-320 | "720-320 CMV IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
40 | 00816057020560 | NC-820096-AM | NC-820096-AM | Detection of CMV Antibody | ASI CMV IgM EIA Test | ARLINGTON SCIENTIFIC, INC. |
41 | 00816057020553 | NC-820096-AG | NC-820096-AG | Detection of CMV Antibody | ASI CMV IgG EIA Test | ARLINGTON SCIENTIFIC, INC. |
42 | 00811727015204 | T8006-96 | T8006-96 | Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of huma Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests. | Pointe Scientific, Inc. CMV IgM | POINTE SCIENTIFIC, INC. |
43 | 00811727015198 | T8005-96 | T8005-96 | Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibo Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests | Pointe Scientific, Inc. CMV IgG | POINTE SCIENTIFIC, INC. |