Compliance Documents

UK

UKCA Declarations of Conformity

LumiraDx Instrument V5E

LumiraDx Instrument V5D

LumiraDx Connect Hub 720-10002-01

LumiraDx CRP Test Strips

LumiraDx CRP Quality Controls

LumiraDx D-Dimer Test Strips

LumiraDx D-Dimer Test Quality Controls

LumiraDx Multi Quality Controls (D-Dimer & CRP)

LumiraDx INR Test Strips

LumiraDx INR Test Quality Controls

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 Ab Quality Controls

LumiraDx SARS-CoV-2 Ab Test Strips

LumiraDx HbA1c Test Strips and Quality Controls

Safety Data Sheets

Lithium Ion Battery Test Declaration

Extraction Buffer

LumiraDx CRP Test Strips

LumiraDx D-Dimer Test Strip

LumiraDx D-Dimer Quality Controls

LumiraDx Multi Quality Controls (D-Dimer & CRP)

LumiraDx INR Test Strip

LumiraDx INR Test Quality Controls

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 HbA1c Test Strips

LumiraDx HbA1c Quality Controls

LumiraDx NT-proBNP Test Strips

LumiraDx NT-proBNP Quality Controls

LumiraDx SARS-CoV-2 Ag Ultra

LumiraDx SARS-CoV-2 and RSV

Europe

Declarations of Conformity

LumiraDx Instrument V5E

LumiraDx Instrument V5D

LumiraDx Connect Hub 720-10002-01

LumiraDx CRP Test Strips

LumiraDx D-Dimer Test Strips

LumiraDx D-Dimer Test Quality Controls

LumiraDx Multi Quality Controls (D-Dimer & CRP)

LumiraDx INR Test Strips

LumiraDx INR Test Quality Controls

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 SARS-CoV-2 Ag Ultra

LumiraDx SARS-CoV-2 Ag Ultra Pool

LumiraDx SARS-CoV-2 & RSV

LumiraDx HbA1c Test Strips and QC

LumiraDx NT-proBNP Test Strips and QC

Safety Data Sheets

Lithium Ion Battery Test Declaration

Extraction Buffer

LumiraDx CRP Test Strips

LumiraDx D-Dimer Test Strip

LumiraDx D-Dimer Quality Controls

LumiraDx Multi Quality Controls (D-Dimer & CRP)

LumiraDx INR Test Strip

LumiraDx INR Test Quality Controls

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 HbA1c Test Strips

LumiraDx HbA1c Quality Controls

LumiraDx NT-proBNP Test Strips

LumiraDx NT-proBNP Quality Controls

LumiraDx SARS-CoV-2 Ag Ultra

LumiraDx SARS-CoV-2 & RSV

Translated Safety Data Sheets

CRP Test SDS BG

CRP Test SDS CE

CRP Test SDS CZ

CRP Test SDS DA

CRP Test SDS DE

CRP Test SDS EN

CRP Test SDS ES

CRP Test SDS FI

CRP Test SDS FR

CRP Test SDS GR

CRP Test SDS HU

CRP Test SDS ID

CRP Test SDS IT

CRP Test SDS JP

CRP Test SDS NL

CRP Test SDS NO

CRP Test SDS PL

CRP Test SDS PT

CRP Test SDS RO

CRP Test SDS SE

CRP Test SDS TR

CRP Test SDS UA

D-Dimer QC SDS DA

D-Dimer QC SDS DE

D-Dimer QC SDS ES

D-Dimer QC SDS FI

D-Dimer QC SDS FR

D-Dimer QC SDS IT

D-Dimer QC SDS NO

D-Dimer QC SDS SE

D-Dimer Test SDS DA

D-Dimer Test SDS DE

D-Dimer Test SDS ES

D-Dimer Test SDS FI

D-Dimer Test SDS FR

D-Dimer Test SDS IT

D-Dimer Test SDS NO

D-Dimer Test SDS SE

HbA1c QC SDS BG

HbA1c QC SDS CZ

HbA1c QC SDS DA

HbA1c QC SDS DE

HbA1c QC SDS EN

HbA1c QC SDS ES

HbA1c QC SDS FI

HbA1c QC SDS FR

HbA1c QC SDS GR

HbA1c QC SDS HU

HbA1c QC SDS ID

HbA1c QC SDS IT

HbA1c QC SDS JP

HbA1c QC SDS NL

HbA1c QC SDS NO

HbA1c QC SDS PL

HbA1c QC SDS PT

HbA1c QC SDS RO

HbA1c QC SDS SE

HbA1c QC SDS TR

HbA1c QC SDS UA

HbA1c Test & Lysis Buffer SDS BG

HbA1c Test & Lysis Buffer SDS CZ

HbA1c Test & Lysis Buffer SDS DA

HbA1c Test & Lysis Buffer SDS DE

HbA1c Test & Lysis Buffer SDS ES

HbA1c Test & lysis buffer SDS FI

HbA1c Test & Lysis Buffer SDS FR

HbA1c Test & Lysis Buffer SDS GR

HbA1c Test & Lysis Buffer SDS HU

HbA1c Test & Lysis Buffer SDS ID

HbA1c Test & lysis buffer SDS IRL

HbA1c Test & Lysis Buffer SDS IT

HbA1c Test & Lysis Buffer SDS JP

HbA1c Test & Lysis Buffer SDS NL

HbA1c Test & Lysis Buffer SDS NO

HbA1c Test & Lysis Buffer SDS PL

HbA1c Test & Lysis Buffer SDS PT(EU)

HbA1c Test & Lysis Buffer SDS RO

HbA1c Test & Lysis Buffer SDS SE

HbA1c Test & Lysis Buffer SDS TR

HbA1c Test & Lysis Buffer SDS UA

INR Test SDS DA

INR Test SDS DE

INR Test SDS ES

INR Test SDS FI

INR Test SDS FR

INR Test SDS IT

INR Test SDS NO

INR Test SDS SE

Multi-QC SDS BG

Multi-QC SDS CZ

Multi-QC SDS DA

Multi-QC SDS DE

Multi-QC SDS EN

Multi-QC SDS ES

Multi-QC SDS FI

Multi-QC SDS FR

Multi-QC SDS GR

Multi-QC SDS HU

Multi-QC SDS ID

Multi-QC SDS IT

Multi-QC SDS JP

Multi-QC SDS NL

Multi-QC SDS NO

Multi-QC SDS PL

Multi-QC SDS PT (EU)

Multi-QC SDS RO

Multi-QC SDS SE

Multi-QC SDS TR

Multi-QC SDS UA

NT-proBNP QC SDS BG

NT-proBNP QC SDS CZ

NT-proBNP QC SDS DA

NT-proBNP QC SDS DE

NT-proBNP QC SDS EN

NT-proBNP QC SDS ES

NT-proBNP QC SDS FI

NT-proBNP QC SDS FR

NT-proBNP QC SDS GR

NT-proBNP QC SDS HU

NT-proBNP QC SDS ID

NT-proBNP QC SDS IT

NT-proBNP QC SDS JP

NT-proBNP QC SDS NL

NT-proBNP QC SDS NO

NT-proBNP QC SDS PL

NT-proBNP QC SDS PT

NT-proBNP QC SDS RO

NT-proBNP QC SDS SE

NT-proBNP QC SDS TR

NT-proBNP QC SDS UA

NT-proBNP Test SDS BG

NT-proBNP Test SDS CZ

NT-proBNP Test SDS DA

NT-proBNP Test SDS DE

NT-proBNP Test SDS ES

NT-proBNP Test SDS FI

NT-proBNP Test SDS FR

NT-proBNP Test SDS GR

NT-proBNP Test SDS HU

NT-proBNP Test SDS ID

NT-proBNP Test SDS IRL

NT-proBNP Test SDS IT

NT-proBNP Test SDS JP

NT-proBNP Test SDS NL

NT-proBNP Test SDS NO

NT-proBNP Test SDS PL

NT-proBNP Test SDS PT(EU)

NT-proBNP Test SDS RO

NT-proBNP Test SDS SE

NT-proBNP Test SDS TR

NT-proBNP Test SDS UA

SARS-CoV-2 & Flu A/B QC Kit SDS AR

SARS-CoV-2 & Flu A/B QC Kit SDS CZ

SARS-CoV-2 & Flu A/B QC Kit SDS DA

SARS-CoV-2 & Flu A/B QC Kit SDS DE

SARS-CoV-2 & Flu A/B QC Kit SDS ES

SARS-CoV-2 & Flu A/B QC Kit SDS FI

SARS-CoV-2 & Flu A/B QC Kit SDS FR

SARS-CoV-2 & Flu A/B QC Kit SDS GR

SARS-CoV-2 & Flu A/B QC Kit SDS HU

SARS-CoV-2 & Flu A/B QC Kit SDS IT

SARS-CoV-2 & Flu A/B QC Kit SDS JP

SARS-CoV-2 & Flu A/B QC Kit SDS KR

SARS-CoV-2 & Flu A/B QC Kit SDS NL

SARS-CoV-2 & Flu A/B QC Kit SDS NO

SARS-CoV-2 & Flu A/B QC Kit SDS PL

SARS-CoV-2 & Flu A/B QC Kit SDS PT

SARS-CoV-2 & Flu A/B QC Kit SDS RO

SARS-CoV-2 & Flu A/B QC Kit SDS SE

SARS-CoV-2 & Flu A/B QC Kit SDS TR

SARS-CoV-2 & Flu A/B SDS FR

SARS-CoV-2 & Flu A/B SDS CZ

SARS-CoV-2 & Flu A/B SDS DA

SARS-CoV-2 & Flu A/B SDS DE

SARS-CoV-2 & Flu A/B SDS EN

SARS-CoV-2 & Flu A/B SDS ES

SARS-CoV-2 & Flu A/B SDS FI

SARS-CoV-2 & Flu A/B SDS GR

SARS-CoV-2 & Flu A/B SDS HU

SARS-CoV-2 & Flu A/B SDS IT

SARS-CoV-2 & Flu A/B SDS NL

SARS-CoV-2 & Flu A/B SDS NO

SARS-CoV-2 & Flu A/B SDS PL

SARS-CoV-2 & Flu A/B SDS PT

SARS-CoV-2 & Flu A/B SDS RO

SARS-CoV-2 & Flu A/B SDS SE

SARS-CoV-2 Ab QC SDS DA

SARS-CoV-2 Ab QC SDS DE

SARS-CoV-2 Ab QC SDS ES

SARS-CoV-2 Ab QC SDS FI

SARS-CoV-2 Ab QC SDS FR

SARS-CoV-2 Ab QC SDS IT

SARS-CoV-2 Ab QC SDS NO

SARS-CoV-2 Ab QC SDS SE

SARS-CoV-2 Ab Test SDS DA

SARS-CoV-2 Ab Test SDS EN

SARS-CoV-2 Ab Test SDS ES

SARS-CoV-2 Ab Test SDS FI

SARS-CoV-2 Ab Test SDS FR

SARS-CoV-2 Ab Test SDS NO

SARS-CoV-2 Ab Test SDS SE

SARS-CoV-2 Ag & RSV Test SDS CE

SARS-CoV-2 Ag & RSV Test SDS CZ

SARS-CoV-2 Ag & RSV Test SDS DA

SARS-CoV-2 Ag & RSV Test SDS DE

SARS-CoV-2 Ag & RSV Test SDS ES

SARS-CoV-2 Ag & RSV Test SDS FI

SARS-CoV-2 Ag & RSV Test SDS FR

SARS-CoV-2 Ag & RSV Test SDS GR

SARS-CoV-2 Ag & RSV Test SDS HU

SARS-CoV-2 Ag & RSV Test SDS IRL

SARS-CoV-2 Ag & RSV Test SDS IT

SARS-CoV-2 Ag & RSV Test SDS NL

SARS-CoV-2 Ag & RSV Test SDS NO

SARS-CoV-2 Ag & RSV Test SDS PL

SARS-CoV-2 Ag & RSV Test SDS PT (EU)

SARS-CoV-2 Ag & RSV Test SDS RO

SARS-CoV-2 Ag & RSV Test SDS SE

SARS-CoV-2 Ag & RSV Test SDS TR

SARS-CoV-2 Ag Extraction Buffer SDS DA

SARS-CoV-2 Ag Extraction Buffer SDS DE

SARS-CoV-2 Ag Extraction Buffer SDS ES

SARS-CoV-2 Ag Extraction Buffer SDS FI

SARS-CoV-2 Ag Extraction Buffer SDS FR

SARS-CoV-2 Ag Extraction Buffer SDS IT

SARS-CoV-2 Ag Extraction Buffer SDS NO

SARS-CoV-2 Ag Extraction Buffer SDS SE

SARS-CoV-2 Ag QC SDS DA

SARS-CoV-2 Ag QC SDS DE

SARS-CoV-2 Ag QC SDS ES

SARS-CoV-2 Ag QC SDS FI

SARS-CoV-2 Ag QC SDS FR

SARS-CoV-2 Ag QC SDS IT

SARS-CoV-2 Ag QC SDS NO

SARS-CoV-2 Ag QC SDS SE

SARS-CoV-2 Ag Test SDS DA

SARS-CoV-2 Ag Test SDS EN

SARS-CoV-2 Ag Test SDS ES

SARS-CoV-2 Ag Test SDS FI

SARS-CoV-2 Ag Test SDS FR

SARS-CoV-2 Ag Test SDS NO

SARS-CoV-2 Ag Test SDS SE

SARS-CoV-2 Ag Ultra Test SDS CE

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Enabling responsive, personal relationships between patients and care teams.

Controlling and reducing costs to help ease pressure on healthcare budgets.

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