Manufacturer's Devices - SpeeDx Pty Ltd
Address:
Suite 102 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 IVD | PCR instrument calibrator kit IVD | IVD 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 control | Neisseria gonorrhoeae nucleic acid IVD control | IVD 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 control | Multiple Mycoplasma species nucleic acid IVD control | IVD General
|
| User-induced pipette | User-induced pipette | Class 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
|