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16 BIT INC

FDA registration
16 BIT INC·1 product·🇨🇦 Canada

The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.

FDA Enforcement
Class II ·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017

Savaria SL-1000 Stairlift

FDA Enforcement
Class II ·Terminated·Savaria Concord Lifts, Inc.·May 17, 2017

Omega Incline Platform Lift

FDA Enforcement
Class II ·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017

ORAgene (Swab-based DNA & Dx Collection Device)

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

Testosterone Saliva ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

Testosterone ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

Resistin ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

Prolactin (PRL) ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

Progesterone ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

Progesterone Saliva ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

Free Estriol ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

Anti-Thyroglobulin (Anti-Tg) ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Diagnostics Biochem Canada Inc.·1 device

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

iSTATIS COVID-19 Ag HOME TEST

Basic UDI-DI
EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

iSTATIS COVID-19 Ag HOME TEST

Basic UDI-DI
EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

iSTATIS COVID-19 Ag TEST

Basic UDI-DI
EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

INSTI COVID ANTIBODY TEST

Basic UDI-DI
EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

INSTI HIV ANTIBODY SELF-TEST

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

INSTI HIV ANTIBODY SELF-TEST

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device