Other products from "GOLD STANDARD DIAGNOSTICS CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B350GSD341600R0 GSD34-1600-R GSD34-1600-R Rapid Plasma Reagin (RPR) Reagent Pack Gold Standard Diagnostics RPR Reagent Pack
2 B350GSD0110260 GSD01-1026 GSD01-1026 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
3 B350GSD011002HCP0 GSD01-1002-HCP GSD01-1002-HCP H. pylori Component Pack PPM General Purpose Reagent 1 H. pylori Component Pack
4 B3507206300 720-630 720-630 ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determinatio ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM antibodies to Epstein-Bar Virus Nuclear Antigen-1 (EBNA-1 IgM) in human serum by indirect enzyme immunoassay. LSE Epstein-Barr Virus, Other 1 Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit
5 B3507205200 720-520 720-520 ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to me ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection. LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg 1 Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit
6 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. LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus 2 Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit
7 B350GSD1600WCASE0 GSD-1600-W-CASE GSD-1600-W-CASE Microtiterplates 48-well microtiter plates - bulk GMQ Antigens, Nontreponemal, All 2 Microtiterplates
8 B350GSD0610190 GSD06-1019 Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit - Bulk LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit
9 B350GSD0130020 GSD01-3002 GSD01-3002 Trichinella spiralis IgG ELISA Test Kit MDT Elisa, Trichinella Spiralis 1 Trichinella spiralis IgG ELISA Test Kit
10 B350GSD0130000 GSD01-3000 GSD01-3000 Toxocara canis IgG ELISA Test Kit MDJ Reagents, Cysticercosis 1 GSD Toxocara canis IgG ELISA
11 B350GSD0110270 GSD01-1027 GSD01-1027 Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit
12 B350GSD0110250 GSD01-1025 GSD01-1025 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
13 B350GSD0110240 GSD10-1024 GSD10-1024 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit
14 B350GSD0110010 GSD01-1001 Gold Standard Diagnostics H. pylori ELISA IgA Test Kit LYR Helicobacter Pylori 1 Gold Standard Diagnostics H. pylori ELISA IgA Test Kit
15 B3507203600 720-360 720-360 ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-qu ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age. LFX Enzyme Linked Immunoabsorbent Assay, Rubella 2 Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit
16 B350005000 00500 00500 Bolt EIA JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 Bolt
17 B350GSD0130070 GSD01-3007 GSD01-3007 Brucella IgG ELISA Test Kit GSM Antisera, Fluorescent, Brucella Spp. 2 GSD Brucella IgG ELISA
18 B350GSD0130010 GSD01-3001 GSD01-3001 Toxocara canis IgG ELISA Test Kit MDJ Reagents, Cysticercosis 1 Toxocara canis IgG ELISA Test Kit
19 B35000300CL0 00300-CL 00300CL ThunderBolt EIA-CLIA JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 ThunderBolt EIA (CLIA)
20 B350GSD1010220 GSD10-1022 GSD10-1022 Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - 10 Pack LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit
21 B350GSD0610180 GSD06-1018 Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - Bulk LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit
22 B350GSD051700AW0 GSD05-1700-AW GSD05-1700-AW HHV-6 IgG Plates - Bulk MVU Reagents, Specific, Analyte 1 HHV-6 IgG Plates - Bulk
23 B350GSD0113000 GSD01-1300 Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 2 Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit
24 B350GSD011029CP0 GSD01-1029-CP GSD01-1029-CP SARS-CoV-2 Component Pack PPM General Purpose Reagent 1 SARS-CoV-2 Component Pack
25 B350GSD0110220 GSD01-1022 GSD01-1022 Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit
26 B350GSD0110180 GSD01-1018 GSD01-1018 Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit
27 B3507203500 720-350 720-350 ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific 2 Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit
28 B350GSD0410220 GSD04-1022 GSD04-1022 Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk Pack LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk
29 B3507205400 720-540 720-540 ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-q ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection. LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus 1 Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit
30 B3507202800 720-280 720-280 ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease. LLL Extractable Antinuclear Antibody, Antigen And Control 2 Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit
31 B350GSD051700CP0 GSD05-1700-CP GSD05-1700-CP IgG Component Pack - Bulk PPM General Purpose Reagent 1 IgG Component Pack - Bulk
32 B350GSD0130100 GSD01-3010 GSD01-3010 Gold Standard Diagnostics Influenza B IgG ELISA Test Kit GNW Antisera, Cf, Influenza Virus A, B, C 1 Influenza B IgG ELISA Test Kit
33 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). QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit
34 B350GSD011029SP0 GSD01-1029-SP GSD01-1029-SP SARS-CoV-2 IgA Sera PackAnalyte Specific Reagent MVU Reagents, Specific, Analyte 1 SARS-CoV-2 IgA Sera Pack
35 B35000500CL0 00500-CL 00500CL Bolt EIA-CLIA JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 Bolt (CLIA)
36 B350003000 00300 00300 JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 ThunderBolt EIA
37 B350GSD0116000 GSD01-1600 Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit GMQ Antigens, Nontreponemal, All 2 Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System
38 B350GSD011002CP0 GSD01-1002-CP GSD01-1002-CP H. pylori IgM Sera Pack MVU Reagents, Specific, Analyte 1 H. pylori IgM Sera Pack
39 B350GSD0110000 GSD01-1000 Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit LYR Helicobacter Pylori 1 Gold Standard Diagnostics H. pylori ELISA IgG Test Kit
40 B3507203400 720-340 720-340 ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific 2 Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit
41 B350004000 00400 AIX1000 Rapid Plasma Reagin (RPR) Analyzer GMQ Antigens, Nontreponemal, All 2 AIX1000 Analyzer
42 B350GSD1010230 GSD10-1023 GSD10-1023 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit
43 B350GSD0410230 GSD04-1023 GSD04-1023 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk Pack LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk
44 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). QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
45 B350GSD0110230 GSD01-1023 GSD01-1023 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit
46 B350GSD0110190 GSD01-1019 GSD01-1019 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit LSR Reagent, Borrelia Serological Reagent 2 Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit
47 B3507203800 720-380 720-380 ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitat ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection. LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster 2 Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit
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7 00884999050464 5.00 09N79-05E Alinity m Resp-4-Plex Application Specification File Alinity m ABBOTT MOLECULAR INC.
8 00884999050457 6.00 09N78-03F Alinity m SARS-CoV-2 Application Specification File Alinity m ABBOTT MOLECULAR INC.
9 00884999050280 09N92-010 09N92-010 Abbott Bulk Universal Collection Kit Alinity m ABBOTT MOLECULAR INC.
10 00884999050242 4.00 09N79-05D Alinity m Resp-4-Plex Application Specification File Alinity m ABBOTT MOLECULAR INC.
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13 00884999050020 1.00 09N79-05C Alinity m ABBOTT MOLECULAR INC.
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15 00884999049406 09N79-086 09N79-086 Alinity m Resp-4-Plex CTRL Kit Alinity m ABBOTT MOLECULAR INC.
16 00884999049390 09N79-096 09N79-096 Alinity m Resp-4-Plex AMP Kit Alinity m ABBOTT MOLECULAR INC.
17 00884999049222 09N78-095 09N78-095 Alinity m SARS-CoV-2 AMP Kit Alinity m ABBOTT MOLECULAR INC.
18 00884999049208 09N78-085 09N78-085 Alinity m SARS-CoV-2 CTRL Kit Alinity m ABBOTT MOLECULAR INC.
19 00884999049185 1.00 09N78-03A Alinity m SARS-CoV-2 Application Specification File Alinity m ABBOTT MOLECULAR INC.
20 00884999049130 09N77-055 09N77-055 Abbott Universal Collection Kit RealTime ABBOTT MOLECULAR INC.
21 00884999049109 09N77-095 09N77-095 Abbott RealTime SARS-CoV-2 Amplification Reagent Kit RealTime ABBOTT MOLECULAR INC.
22 00884999049086 09N77-085 09N77-085 Abbott RealTime SARS-CoV-2 Control Kit RealTime ABBOTT MOLECULAR INC.
23 00884999049055 09N77-010 09N77-010 Abbott RealTime SARS-CoV-2 Application CD-ROM RealTime ABBOTT MOLECULAR INC.
24 00815381020482 423738 IVD reagent kit containing 30 tests. BioFire® Respiratory Panel 2.1 EUA BIOFIRE DIAGNOSTICS, LLC
25 00815381020239 423883 IVD reagent kit containing 30 tests. BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests BIOFIRE DIAGNOSTICS, LLC
26 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.
27 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.
28 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.
29 B379COV2E0 COV2-E EUA Smart DetectTM SARS-CoV-2 rRT-PCR Kit INBIOS INTERNATIONAL, INC
30 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
31 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
32 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
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