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4 B379DDMS11 DDMS1 DDMS-1 OSU Dengue Serological Reagents 2 DENV Detect IgM Capture ELISA
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6 B379CL0251 CL025 CL025 PIT Leishmania Spp. Antigen Detection Assay 1 CL Detect Rapid Test for Cutaneous Leishmaniasis
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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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.
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12 00884999050020 1.00 09N79-05C Alinity m ABBOTT MOLECULAR INC.
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14 00884999049406 09N79-086 09N79-086 Alinity m Resp-4-Plex CTRL Kit Alinity m ABBOTT MOLECULAR INC.
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17 00884999049208 09N78-085 09N78-085 Alinity m SARS-CoV-2 CTRL Kit Alinity m ABBOTT MOLECULAR INC.
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19 00884999049130 09N77-055 09N77-055 Abbott Universal Collection Kit RealTime ABBOTT MOLECULAR INC.
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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
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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.
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