289 results · 151ms · Sources: EU EUDAMED, US FDA

FDA Pre-Market Approval
AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085023250·Sodium Citrate Solution 250ml bottle

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020266·NAC-PAC RED (3.0%), 50mL

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085022048·Nocardia/Actinomyces Stain Wash 1x250ml

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085022963·NAC-PAC (2.0%) 50ml bottle

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020877·NALC tablets 1x10ea

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020471·Gram Stain Control Slides With 3 Patient Wells

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085024035·0.9% Saline 4.0ml

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020440·Gram Stain QC Slides (10 Pk)

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085020594·CELL-BOND Slides, no wells or background

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085021423·PROTO-FIX bag kit

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085021942·NAC-PAC Unitary 3.0% Tray

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085023373·NAC-PAC (3.0%) 200ml bottle

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085021768·Oxalic Acid 20x5ml

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085022697·PRO-CLEAR 1L

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085022291·AFB Base Decontamination Reagent (2.5%) 250ml b...

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085021461·PROTO-FIX [2 Vials] /Clean Vial bag kit

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085022208·Sodium Carbonate 5x150mg

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085023151·NAC-PAC (3.0%) 5x50ml

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085024042·NAC-PAC EA3 (2.5%) tray w/ NALC powder