74 results · 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