Compliance Documents

Declarations of Conformity

LumiraDx Instrument V5E

LumiraDx Instrument V5D

LumiraDx Connect Hub 720-10002-01

LumiraDx SARS-CoV-2 Ag Test Strips

LumiraDx SARS-CoV-2 Ag Quality Controls

LumiraDx SARS-CoV-2 Flu AB Test Strips and QC

LumiraDx SARS-CoV-2 Ag Pool Test

LumiraDx SARS-CoV-2 Ab Test Strips

LumiraDx INR Test Strips

LumiraDx INR Test Quality Controls

LumiraDx D-Dimer Test Strips

LumiraDx D-Dimer Test Quality Controls

LumiraDx CRP Test Strips

LumiraDx Multi Quality Controls (D-Dimer & CRP)

LumiraDx SARS-CoV-2 Ag Ultra

LumiraDx SARS-CoV-2 Ag Ultra Pool

LumiraDx SARS-CoV-2 & RSV

Safety Data Sheets

Lithium Ion Battery Test Declaration

Extraction Buffer

LumiraDx SARS-CoV-2 Ag Test Strips

LumiraDx SARS-CoV-2 Ag Quality Controls Kit

LumiraDx SARS-CoV-2 Ab Test Strips

LumiraDx SARS-CoV-2 Ab Quality Controls

LumiraDx SARS-CoV-2 Ag and Flu A/B Test Strips

LumiraDx SARS-CoV-2 Ag and Flu A/B Quality Controls

LumiraDx D-Dimer Test Strip

LumiraDx D-Dimer Quality Controls

LumiraDx INR Test Strip

LumiraDx INR Test Quality Controls

LumiraDx CRP Test Strips

LumiraDx Multi Quality Controls (D-Dimer & CRP)