No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04049016045403 | FA 1522-2010 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
2 | 04049016045397 | FA 1522-2005 | ANA IFA: HEp-20-10 | |||||
3 | 04049016045380 | FA 1522-2003 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
4 | 04049016145745 | MP 2606-0200 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
5 | 04049016145691 | MP 2606-0100 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
6 | 04049016145660 | MP 2606-0425 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
7 | 04049016145653 | MP 2606-0225 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
8 | 04049016145646 | MP 2606-0125 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
9 | 04049016114895 | EI 2132-9601-24 O | LSR | Reagent, Borrelia Serological Reagent | 2 | Lyme ELISA (IgG/IgM) | ||
10 | 04049016109723 | YG 0153-0101 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | EUROBlotOne | ||
11 | 04049016109709 | YG 0033-0101-5 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | Sprinter XL (model 160 samples, IFA) | ||
12 | 04049016109693 | YG 0033-0101-4 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | Sprinter XL (model 160 samples, IFA incl. incubator) | ||
13 | 04049016109679 | YG 0033-0101-26 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Sprinter XL (model 240 samples, IFA/ELISA) | ||
14 | 04049016096047 | EI 2050-9601 M | GOX | Antigen, B. Pertussis | 1 | Anti-Bordetella pertussis ELISA (IgM) | ||
15 | 04049016092575 | FA 112d-2010-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
16 | 04049016092568 | FA 112d-2005-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
17 | 04049016092551 | FA 112d-1010-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
18 | 04049016092544 | FA 112d-1005-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
19 | 04049016092537 | FA 112d-1003-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
20 | 04049016091608 | EA 1502-4801-1 G | OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | 2 | Anti-BP230-CF ELISA (IgG) | ||
21 | 04049016091288 | FA 1201-2010-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
22 | 04049016091271 | FA 1201-2005-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
23 | 04049016091264 | FA 1201-1010-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
24 | 04049016091257 | FA 1201-1005-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
25 | 04049016091240 | FA 1201-1003-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
26 | 04049016089193 | EA 1496-4801 G | NBO | Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3) | 2 | Anti-Desmoglein 3 ELISA (IgG) | ||
27 | 04049016089186 | EA 1495-4801 G | NBO | Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3) | 2 | Anti-Desmoglein 1 ELISA (IgG) | ||
28 | 04049016085478 | DN 2050-24001 G | GOX | Antigen, B. Pertussis | 1 | EUROLINE Bordetella pertussis (IgG) | ||
29 | 04049016085447 | DN 2050-1601 G | GOX | Antigen, B. Pertussis | 1 | EUROLINE Bordetella pertussis (IgG) | ||
30 | 04049016068822 | YG 0151-0101 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | EUROBlotMaster | ||
31 | 04049016067887 | FI 2861-2005 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
32 | 04049016067870 | FI 2861-1010 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
33 | 04049016067863 | FI 2861-1005 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
34 | 04049016067856 | FI 2861-1003 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
35 | 04049016045366 | FA 1522-1050 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
36 | 04049016045359 | FA 1522-1010 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
37 | 04049016045342 | FA 1522-1005 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
38 | 04049016045335 | FA 1522-1003 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
39 | 04049016035930 | EV 3011-9601 A | MST | Antibodies, Gliadin | 2 | Anti-Gliadin (GAF-3X) ELISA (IgA) | ||
40 | 04049016028369 | EI 2721-9601-1 A | GQT | Antisera, Cf, Parainfluenza Virus 1-4 | 1 | Anti-Parainfluenza Viruses Pool ELISA (IgA) | ||
41 | 04049016028321 | EI 2691-9601-1 G | GNS | Antisera, Hai, Influenza Virus A, B, C | 1 | Anti-Influenza A/B Virus Pool ELISA (IgG) | ||
42 | 04049016027560 | EI 2189-9601 G | GSM | Antisera, Fluorescent, Brucella Spp. | 2 | Anti-Brucella abortus ELISA (IgG) | ||
43 | 04049016027522 | EI 2150-9601 M | MJH | Legionella, Spp., Elisa | 2 | Anti-Legionella pneumophila ELISA (IgM) | ||
44 | 04049016134992 | DY 2133-24001-1 M | LSR | Reagent, Borrelia Serological Reagent | 2 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | ||
45 | 04049016134985 | DY 2133-3001-1 M | LSR | Reagent, Borrelia Serological Reagent | 2 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | ||
46 | 04049016119999 | FC 1911-0010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern | ||
47 | 04049016119982 | FC 1911-2010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | IFA: Oesophagus (Monkey) IgA EUROPattern | |||
48 | 04049016119975 | FC 1911-2005 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern | ||
49 | 04049016119968 | FC 1911-1010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern | ||
50 | 04049016119951 | FC 1911-1005 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04260157080034 | ORG506 | ORG506 | ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUT ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS (ena) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGONSTIC USE ONLY. | ENASCREEN | ORGENTEC DIAGNOSTIKA GMBH |
2 | 04250289502924 | 7102US | 7102US | AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitativ AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6S | AESKU.DIAGNOSTICS GMBH & CO. KG |
3 | 04250289500449 | 3102 | AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitativ AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6S | AESKU.DIAGNOSTICS GMBH & CO. KG | |
4 | 04049016124917 | DL 1590-6401-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
5 | 04049016124900 | DL 1590-1601-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
6 | 04049016086017 | EA 1590-9601-9 G | Anti-ENA Pool ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
7 | 04049016084785 | DL 1590-6401-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
8 | 04049016083139 | DL 1590-1601-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
9 | 04049016027232 | EA 1661-9601 G | Anti-Jo-1 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
10 | 04049016027058 | EA 1599-9601 G | Anti-Scl-70 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
11 | 04049016027041 | EA 1597-9601 G | Anti-SS-B ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
12 | 04049016027034 | EA 1595-9601 G | Anti-SS-A ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
13 | 04048474035711 | EIA-3571 | EIA-3571 | ENA Screen ELISA is a test system for the qualitative screening of IgG class aut ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma .samples. | ENA Screen ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
14 | 00850487007630 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
15 | 00850487007623 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
16 | 00850487007487 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
17 | 00850487007258 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
18 | 00847865012331 | SW4.1_V2 | 6651170D | ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
19 | 00847865002721 | SW4_V2 | 6651160G | Manual & CDs, ANA Screen with MDSS IFU, SW 4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
20 | 00847865002448 | SW4_V2 | 6651170C | ANA Screen with MDSS Assay Protocol File CD, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
21 | 00847865001342 | SW4.1_V2 | 6651160H | Manual & CDs, ANA Screen with MDSS IFU, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
22 | 00847865000093 | 6651155 | 6651155 | ANA Screen with MDSS Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
23 | 00847865000086 | 6651150 | 6651150 | ANA Screen with MDSS Reagent pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
24 | 00847817022425 | 96SB | 96SB | Autoimmune EIA Anti-SS-B/La Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
25 | 00847817022418 | 96SA | 96SA | Autoimmune EIA Anti-SS-A/Ro Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
26 | 00847817022388 | 96EP | 96EP | Autoimmune EIA ENA Plus Screening test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
27 | 00847817022340 | 96CE | 96CE | Autoimmune EIA Anti-Centromere Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
28 | 00847817006944 | 220HSP | 220HSP | Autoimmune EIA ENA Conjugate, 15 mL | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
29 | 00845714004247 | 2308-1 | 2308-1 | WASH BUFFER | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
30 | 00845714002960 | 5308 | 5308 | Serum Diluent | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
31 | 00845714002922 | 2514 | 2514 | TMB Substrate | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
32 | 00845714002786 | 2316 | 2316 | Stop Solution | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
33 | 00845714002311 | 5150 | 5150 | Sci-70 Antibody Elisa | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
34 | 00845714002267 | 5129 | 5129 | SS-B (La) Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
35 | 00845714002243 | 5127 | 5127 | Sm Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
36 | 00845714002236 | 5126 | 5126 | RNP Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
37 | 00817273020129 | 720-290 | "720-290 anti-Jo-1 Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
38 | 00817273020112 | 720-280 | "720-280 anti-Scl-70 Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
39 | 00817273020105 | 720-270 | "720-270 anti-SM/RNP Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
40 | 00817273020099 | 72-260 | 720-260 anti-SSB Test Kit | Diamedix | DIAMEDIX CORPORATION | |
41 | 00817273020082 | 720-250 | 720-250 anti-SSA Test Kit | Diamedix | DIAMEDIX CORPORATION | |
42 | 00817273020075 | 720-240 | 720-240 anti-SM Test Kit | Diamedix | DIAMEDIX CORPORATION | |
43 | 00817273020068 | 720-230 | 720-230 ENA-6 Screen Test Kit | Diamedix | DIAMEDIX CORPORATION | |
44 | 00817273020051 | 720-130 | 720-130 H.pylori IgG Test Kit | Diamedix | DIAMEDIX CORPORATION | |
45 | 00817273020044 | 300-371A | "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit" | Diamedix | DIAMEDIX CORPORATION | |
46 | 00816879020380 | FGA38 | 96 well ELISA for the detection of ENA antibodies in human serum | Autostat II Anti-ENA-6 Profile | HYCOR BIOMEDICAL LLC | |
47 | 00816879020342 | FGA34 | 96 well ELISA for the detection of anti-Scl-70 antibodies in human serum | Autostat II Anti-Scl-70 | HYCOR BIOMEDICAL LLC | |
48 | 00816879020335 | FGA33 | 96 well ELISA for the detection of Anti-Jo-1 antibodies in human serum | Autostat II Anti-Jo-1 | HYCOR BIOMEDICAL LLC | |
49 | 00816879020304 | FGA30 | 96 well ELISA for the detection of Anti-SS-B/La antibodies in human serum | Autostat II Anti-SS-B/La | HYCOR BIOMEDICAL LLC | |
50 | 00816879020298 | FGA29 | 96 well ELISA for the detection of Anti-SS-A/Ro antibodies in human serum | Autostat II Anti-SS-A/Ro | HYCOR BIOMEDICAL LLC |