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 | 04049016145653 | MP 2606-0225 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
7 | 04049016145646 | MP 2606-0125 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
8 | 04049016114895 | EI 2132-9601-24 O | LSR | Reagent, Borrelia Serological Reagent | 2 | Lyme ELISA (IgG/IgM) | ||
9 | 04049016109723 | YG 0153-0101 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | EUROBlotOne | ||
10 | 04049016109709 | YG 0033-0101-5 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | Sprinter XL (model 160 samples, IFA) | ||
11 | 04049016109693 | YG 0033-0101-4 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | Sprinter XL (model 160 samples, IFA incl. incubator) | ||
12 | 04049016109679 | YG 0033-0101-26 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Sprinter XL (model 240 samples, IFA/ELISA) | ||
13 | 04049016096047 | EI 2050-9601 M | GOX | Antigen, B. Pertussis | 1 | Anti-Bordetella pertussis ELISA (IgM) | ||
14 | 04049016092575 | FA 112d-2010-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
15 | 04049016092568 | FA 112d-2005-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
16 | 04049016092551 | FA 112d-1010-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
17 | 04049016092544 | FA 112d-1005-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
18 | 04049016092537 | FA 112d-1003-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
19 | 04049016091608 | EA 1502-4801-1 G | OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | 2 | Anti-BP230-CF ELISA (IgG) | ||
20 | 04049016091288 | FA 1201-2010-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
21 | 04049016091271 | FA 1201-2005-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
22 | 04049016091264 | FA 1201-1010-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
23 | 04049016091257 | FA 1201-1005-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
24 | 04049016091240 | FA 1201-1003-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
25 | 04049016089193 | EA 1496-4801 G | NBO | Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3) | 2 | Anti-Desmoglein 3 ELISA (IgG) | ||
26 | 04049016089186 | EA 1495-4801 G | NBO | Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3) | 2 | Anti-Desmoglein 1 ELISA (IgG) | ||
27 | 04049016086017 | EA 1590-9601-9 G | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Anti-ENA Pool 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 | 04049016145745 | MP 2606-0200 | EURORealTime SARS-CoV-2 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
2 | 04049016145691 | MP 2606-0100 | EURORealTime SARS-CoV-2 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
3 | 04049016145660 | MP 2606-0425 | EURORealTime SARS-CoV-2 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
4 | 04049016145653 | MP 2606-0225 | EURORealTime SARS-CoV-2 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
5 | 04049016145646 | MP 2606-0125 | EURORealTime SARS-CoV-2 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
6 | 00884999050464 | 5.00 | 09N79-05E | Alinity m Resp-4-Plex Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
7 | 00884999050457 | 6.00 | 09N78-03F | Alinity m SARS-CoV-2 Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
8 | 00884999050280 | 09N92-010 | 09N92-010 | Abbott Bulk Universal Collection Kit | Alinity m | ABBOTT MOLECULAR INC. |
9 | 00884999050242 | 4.00 | 09N79-05D | Alinity m Resp-4-Plex Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
10 | 00884999050211 | 5.00 | 09N78-03E | Alinity m SARS-CoV-2 Application Specification | Alinity m | ABBOTT MOLECULAR INC. |
11 | 00884999050136 | 4.00 | 09N78-03D | Alinity m SARS COV-2 Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
12 | 00884999050020 | 1.00 | 09N79-05C | Alinity m | ABBOTT MOLECULAR INC. | |
13 | 00884999049413 | 1.00 | 09N79-05A | Alinity m Resp-4-Plex Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
14 | 00884999049406 | 09N79-086 | 09N79-086 | Alinity m Resp-4-Plex CTRL Kit | Alinity m | ABBOTT MOLECULAR INC. |
15 | 00884999049390 | 09N79-096 | 09N79-096 | Alinity m Resp-4-Plex AMP Kit | Alinity m | ABBOTT MOLECULAR INC. |
16 | 00884999049222 | 09N78-095 | 09N78-095 | Alinity m SARS-CoV-2 AMP Kit | Alinity m | ABBOTT MOLECULAR INC. |
17 | 00884999049208 | 09N78-085 | 09N78-085 | Alinity m SARS-CoV-2 CTRL Kit | Alinity m | ABBOTT MOLECULAR INC. |
18 | 00884999049185 | 1.00 | 09N78-03A | Alinity m SARS-CoV-2 Application Specification File | Alinity m | ABBOTT MOLECULAR INC. |
19 | 00884999049130 | 09N77-055 | 09N77-055 | Abbott Universal Collection Kit | RealTime | ABBOTT MOLECULAR INC. |
20 | 00884999049109 | 09N77-095 | 09N77-095 | Abbott RealTime SARS-CoV-2 Amplification Reagent Kit | RealTime | ABBOTT MOLECULAR INC. |
21 | 00884999049086 | 09N77-085 | 09N77-085 | Abbott RealTime SARS-CoV-2 Control Kit | RealTime | ABBOTT MOLECULAR INC. |
22 | 00884999049055 | 09N77-010 | 09N77-010 | Abbott RealTime SARS-CoV-2 Application CD-ROM | RealTime | ABBOTT MOLECULAR INC. |
23 | 00815381020482 | 423738 | IVD reagent kit containing 30 tests. | BioFire® Respiratory Panel 2.1 EUA | BIOFIRE DIAGNOSTICS, LLC | |
24 | 00815381020239 | 423883 | IVD reagent kit containing 30 tests. | BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests | BIOFIRE DIAGNOSTICS, LLC | |
25 | B540D20010 | D2001 | D2001 | The Programming Cassette is an accessory to the Accula Dock and facilitates repr The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware | Accula Programming Cassette | MESA BIOTECH, INC. |
26 | B540D20000 | D2000 | D2000 | The Accula Dock is an electronic module which executes in vitro diagnostic tests The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of anelectro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary toorchestrate in-vitro diagnostic tests within the inserted Test Cassette. | Accula Dock | MESA BIOTECH, INC. |
27 | B540COV41000 | COV4100 | COV4100 | The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock i The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection. | Accula SARS-CoV-2 Test | MESA BIOTECH, INC. |
28 | B379COV2E0 | COV2-E | EUA | Smart DetectTM SARS-CoV-2 rRT-PCR Kit | INBIOS INTERNATIONAL, INC | |
29 | B350GSD0110300 | GSD01-1030 | GSD01-1030 | Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
30 | B350GSD0110290 | GSD01-1029 | GSD01-1029 | Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
31 | B350GSD0110280 | GSD01-1028 | GSD01-1028 | Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
32 | 30014613339656 | Coronavirus | M313 | Solana SARS-CoV-2 Assay | Solana SARS-CoV-2 Assay | DIAGNOSTIC HYBRIDS, INC. |
33 | 30014613339144 | Coronavirus | M124 | SARS-CoV-2 Direct Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
34 | 30014613339090 | Coronavirus | M120 | Lyra SARS-CoV-2 Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
35 | 10814278021264 | 300800 | 300800 | NeuMoDx SARS-CoV-2 Test Strip | NEUMODX MOLECULAR, INC. |