Manufacturer's Devices - SpeeDx Pty Ltd

Address:




Suite G16 National Innovation Centre 4 Cornwallis Street



Eveleigh

NSW 2015

Australia


Authorised Representative/ UK Responsible Person
Name: SpeeDx Ltd
Address:

Acre House 11/15 William Road



London

NW1 3ER

England United Kingdom




Code/Term Type
PCR instrument calibrator kit IVDPCR instrument calibrator kit IVDIVD General
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Neisseria gonorrhoeae nucleic acid IVD controlNeisseria gonorrhoeae nucleic acid IVD controlIVD General
Neisseria gonorrhoeae nucleic acid IVD kit nucleic acid technique (NAT)Neisseria gonorrhoeae nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple Mycoplasma species nucleic acid IVD kit nucleic acid technique (NAT)Multiple Mycoplasma species nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple Mycoplasma species nucleic acid IVD controlMultiple Mycoplasma species nucleic acid IVD controlIVD General
User-induced pipetteUser-induced pipetteClass I
Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General