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 | 04049016086017 | EA 1590-9601-9 G | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Anti-ENA Pool ELISA (IgG) | ||
29 | 04049016085478 | DN 2050-24001 G | GOX | Antigen, B. Pertussis | 1 | EUROLINE Bordetella pertussis (IgG) | ||
30 | 04049016085447 | DN 2050-1601 G | GOX | Antigen, B. Pertussis | 1 | EUROLINE Bordetella pertussis (IgG) | ||
31 | 04049016068822 | YG 0151-0101 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | EUROBlotMaster | ||
32 | 04049016067887 | FI 2861-2005 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
33 | 04049016067870 | FI 2861-1010 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
34 | 04049016067863 | FI 2861-1005 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
35 | 04049016067856 | FI 2861-1003 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
36 | 04049016045366 | FA 1522-1050 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
37 | 04049016045359 | FA 1522-1010 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
38 | 04049016045342 | FA 1522-1005 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
39 | 04049016045335 | FA 1522-1003 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
40 | 04049016035930 | EV 3011-9601 A | MST | Antibodies, Gliadin | 2 | Anti-Gliadin (GAF-3X) ELISA (IgA) | ||
41 | 04049016028369 | EI 2721-9601-1 A | GQT | Antisera, Cf, Parainfluenza Virus 1-4 | 1 | Anti-Parainfluenza Viruses Pool ELISA (IgA) | ||
42 | 04049016028321 | EI 2691-9601-1 G | GNS | Antisera, Hai, Influenza Virus A, B, C | 1 | Anti-Influenza A/B Virus Pool ELISA (IgG) | ||
43 | 04049016027560 | EI 2189-9601 G | GSM | Antisera, Fluorescent, Brucella Spp. | 2 | Anti-Brucella abortus ELISA (IgG) | ||
44 | 04049016027522 | EI 2150-9601 M | MJH | Legionella, Spp., Elisa | 2 | Anti-Legionella pneumophila ELISA (IgM) | ||
45 | 04049016134992 | DY 2133-24001-1 M | LSR | Reagent, Borrelia Serological Reagent | 2 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | ||
46 | 04049016134985 | DY 2133-3001-1 M | LSR | Reagent, Borrelia Serological Reagent | 2 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | ||
47 | 04049016119999 | FC 1911-0010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern | ||
48 | 04049016119982 | FC 1911-2010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | IFA: Oesophagus (Monkey) IgA EUROPattern | |||
49 | 04049016119975 | FC 1911-2005 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern | ||
50 | 04049016119968 | FC 1911-1010 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 | 07350008750098 | Precision i5 | Stationary x-ray system intended for obtaining radiographic images portions of t Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography. | OMNERA 500A | ARCOMA AB | |
2 | 07340058410943 | CapMPO US | CapMPO US | WIESLAB Capture MPO-ANCA | EURO-DIAGNOSTICA AB | |
3 | 07340058410936 | CapPR3 US | CapPR3 US | WIESLAB Capture PR3 ANCA | EURO-DIAGNOSTICA AB | |
4 | 07340058410707 | GCP100 | GCP100 | WIESLAB antiGBM, ANCA Screen kit | EURO-DIAGNOSTICA AB | |
5 | 07340058410639 | CP111 | CP111 | WIESLAB ANCA Screen kit | EURO-DIAGNOSTICA AB | |
6 | 07333066014784 | DECC055370 | DECC055370 | EliA MPOS Well | EliA MPOS Well | PHADIA AB |
7 | 07333066014777 | DECC055360 | DECC055360 | EliA PR3S Well | EliA PR3S Well | PHADIA AB |
8 | 07333066014630 | DECC055140 | DECC055140 | EliA GBM Well | EliA GBM Well | PHADIA AB |
9 | 07333066013152 | 83-0008-71 | 83-0008-71 | EliA ANCA/GBM Positive Control 2500/5000 | EliA ANCA/GBM Positive Control 2500/5000 | PHADIA AB |
10 | 05391516748018 | 10-5602 | 10-5602 | GBM Positive Control, 0.5 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
11 | 05391516748001 | 10-5648 | 10-5648 | Glomerular Basement Membrane IFA Test System, 48 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
12 | 05391516747943 | 90-1610 | 90-1610 | FITC Mounting Medium (pH 7.5), 3.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
13 | 05391516747585 | 90-1607 | 90-1607 | Phosphate Buffered Saline, 10g | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
14 | 05391516743891 | 2338970 | 2338970 | Captia™ PR-3 | Trinity Biotech | CLARK LABORATORIES, INC. |
15 | 05391516743877 | 2338870 | 2338870 | Captia™ MPO | Trinity Biotech | CLARK LABORATORIES, INC. |
16 | 04260186125096 | AUTOMATED IFA SYSTEM | IOS-1000 | Automated system for immunofluorescence processing with an integral fluorescence Automated system for immunofluorescence processing with an integral fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. | HELIOS | AESKU.SYSTEMS GMBH & CO. KG |
17 | 04260157080188 | ORG519 | ORG519 | Anti-MPO is an ELISA test system for the quantitative measurement of IgG class a Anti-MPO is an ELISA test system for the quantitative measurement of IgG class autoantibodies against myeloperoxidase (MPO) in human serum or plasma. This product is intended for professional in vitro diagnostic use only. | ANTI-MPO (pANCA) | ORGENTEC DIAGNOSTIKA GMBH |
18 | 04260157080171 | ORG518 | ORG518 | Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class a Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. This product is intended for professional in vitro diagnostic use only. | ANTI-PR3 (cANCA) | ORGENTEC DIAGNOSTIKA GMBH |
19 | 04250289510387 | 54.051.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Formalin | AESKU.DIAGNOSTICS GMBH & CO. KG | |
20 | 04250289510370 | 54.050.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Ethanol | AESKU.DIAGNOSTICS GMBH & CO. KG | |
21 | 04250289510363 | 54.101.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Formalin | AESKU.DIAGNOSTICS GMBH & CO. KG | |
22 | 04250289510356 | 54.100.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | AESKUSLIDES ANCA Ethanol | AESKU.DIAGNOSTICS GMBH & CO. KG | |
23 | 04250289503556 | 30-7303US | 30-7303US | AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified nati AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. 30'+30'+30' automation incubation. | AESKULISA® MPO | AESKU.DIAGNOSTICS GMBH & CO. KG |
24 | 04250289503549 | 30-7302US | 30-7302US | AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly pur AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis.30'+30'+30' automation incubation. | AESKULISA® PR3 sensitive | AESKU.DIAGNOSTICS GMBH & CO. KG |
25 | 04250289501361 | 3303 | AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified nati AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. | AESKULISA® MPO | AESKU.DIAGNOSTICS GMBH & CO. KG | |
26 | 04250289501354 | 3302 | AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly pur AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis | AESKULISA® PR3 sensitive | AESKU.DIAGNOSTICS GMBH & CO. KG | |
27 | 04049016135975 | FC 1201-18010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
28 | 04049016135975 | FC 1201-18010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
29 | 04049016135968 | FC 1201-18010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
30 | 04049016135968 | FC 1201-18010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
31 | 04049016135968 | FC 1201-18010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
32 | 04049016135951 | FC 1201-18010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
33 | 04049016135951 | FC 1201-18010-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
34 | 04049016135944 | FC 1201-18010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
35 | 04049016135944 | FC 1201-18010-2 | IFA: Granulocyte Mosaic 2 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
36 | 04049016135937 | FC 1201-18010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
37 | 04049016135937 | FC 1201-18010-13 | IFA: Granulocyte Mosaic 13 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
38 | 04049016135920 | FC 1201-12010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
39 | 04049016135920 | FC 1201-12010-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
40 | 04049016135913 | FC 1201-2450-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
41 | 04049016135913 | FC 1201-2450-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
42 | 04049016135906 | FC 1201-1050-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
43 | 04049016135906 | FC 1201-1050-32 | EUROPLUS Granulocyte Mosaic 32 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
44 | 04049016135890 | FC 1201-12010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
45 | 04049016135890 | FC 1201-12010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
46 | 04049016135890 | FC 1201-12010-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
47 | 04049016135883 | FC 1201-2450-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
48 | 04049016135883 | FC 1201-2450-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
49 | 04049016135883 | FC 1201-2450-25 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
50 | 04049016135876 | FC 1201-2450-22 | EUROPLUS Granulocyte Mosaic 22 EUROPattern | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG |