74 results
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42ms
·
Sources: EU EUDAMED, US FDA
T2Bacteria Panel
FDA registration
T2 BIOSYSTEMS, INC.·2 products·🇺🇸 United States
T2Candida 1.1 Panel
FDA 510(k)
FDA Class 2
·Microbiology
T2CANDIDA AND T2DX INSTRUMENT
FDA 510(k)
FDA Class 2
·Microbiology
T2Bacteria Panel
FDA 510(k)
FDA Class 2
·Microbiology
T2Candida 1.1 Panel
FDA 510(k)
FDA Class 2
·Microbiology
T2Bacteria® Panel
FDA 510(k)
FDA Class 2
·Microbiology
T2 Biothreat Panel
FDA registration
T2 BIOSYSTEMS, INC.·3 products·🇺🇸 United States
T2Biothreat® QCheck Negative Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70885113983·Negative quality control for T2Biothreat Panel
T2Biothreat® Reagent Trays
FDA UDI
T2 BIOSYSTEMS, INC.·M70880113943·The T2Biothreat Panel component that contains t...
T2Biothreat® Cartridge Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70890114000·The T2Biothreat Panel components used to load t...
T2Biothreat® QCheck Positive Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70885113963·Buffer based solution with containing non-patho...
Direct Blood Bacterial Nucleic Acid Detection System
FDA classification
FDA Class 2
·Direct Blood Bacterial Nucleic Acid Detection System
Candida Species Nucleic Acid Detection System
FDA classification
FDA Class 2
·Candida Species Nucleic Acid Detection System
Rabies DFA
FDA registration
EMD MILLIPORE CORPORATION·1 product·🇺🇸 United States
QDXB50 - Blastomyces CF Antigen
FDA registration
IMMY, Inc.·1 product·🇺🇸 United States
FITC Anti-Rabies Monoclonal Globulin
FDA registration
Fujirebio Diagnostics, Inc.·1 product·🇺🇸 United States
BTA101 - OMEGA Blastomyces Total Antibody EIA
FDA registration
IMMY, Inc.·1 product·🇺🇸 United States
Blastomyces ID Positive Control
FDA registration
IMMY, Inc.·1 product·🇺🇸 United States
FITC Anti-Rabies Monoclonal Globulin
FDA UDI
FUJIREBIO DIAGNOSTICS, INC.·00850212007003·
IMMY
FDA UDI
Immuno-Mycologics, Inc.·00816387020575·Blastomyces CF Antigen