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LumiraDx SARS-CoV-2 Ag Test (48 Tests)

The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay for direct and qualitative detection of nucleocapsid proteins in nasal swab specimens from patients suspected of COVID-19.Used with the LumiraDx Instrument the Test delivers rapid results at the point-of-care.Easy to implement in point-of-care settings:

  • Clinical performance: 97.6% positive percent agreement, 96.6% negative percent agreement
  • Analytical performance with a limit of detection of 32 TCID50/mL
  • RT-PCR comparable results within 12 days of onset of symptoms

48 tests per kit.Materials provided:

  • LumiraDx Test Strips packed individually in sealed desiccant foil pouches.
  • LumiraDx Test Product Insert
  • RFID (Radio frequency ID) Tag held inside the Test Strip carton
  • Extraction Buffer Vials
  • Dropper Lids
  • LumiraDx SARS-CoV-2 Ag Test Quick Reference Instructions

Materials required but not provided with the Test Strip carton:

  • LumiraDx Instrument
  • Standard nasal swab collection equipment.  Please see the LumiraDx Technical Bulletin for a list of swabs which have been validated for use with the SARS-CoV-2 Ag Test.
  • LumiraDx SARS-CoV-2 Ag Quality Controls (as required to meet local and organisational compliance)

Authorised by the FDA under an Emergency Use Authorisation (EUA).

Weight 0.48 kg
Dimensions 23.5 × 20 × 9 cm
Certification

AMA, BRC, BSI, CE, CE-IVD, CE/UL, CE/UL/Energy Star, CE/WHO PQS, CEE, CFDA, DOC, EAC, EC, ECM, ENERGY STAR, EU-RED, EUA, FCC, FDA, FDA EUA, FDA/CE, HSA, ISO, ISO/CE, ISO/FDA/CE, KC, Korean-FDA, MDEL, MHRA, NDA, NIH, NIOSH, NMPA, NMPA/CE, NMPA/CE/FDA-EUA/WHO-EUL/ANVISA/TGA, NMRC, NOISH, NQA, NRCS, PEUA FDA, PMPB, PPB, RFDA, RoHS, SABS, SAHPRA, SGS, SON, TGA, TMDA, UL, WHO, WHO PQS, ZAMRA

Incoterms

EXW

$120.00

18943 in stock

The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay for direct and qualitative detection of nucleocapsid proteins in nasal swab specimens from patients suspected of COVID-19.Used with the LumiraDx Instrument the Test delivers rapid results at the point-of-care.Click here to see full test details and a 3 minute “How to run an Antigen test video”.

Additional information

Weight 0.48 kg
Dimensions 23.5 × 20 × 9 cm
Certification

AMA, BRC, BSI, CE, CE-IVD, CE/UL, CE/UL/Energy Star, CE/WHO PQS, CEE, CFDA, DOC, EAC, EC, ECM, ENERGY STAR, EU-RED, EUA, FCC, FDA, FDA EUA, FDA/CE, HSA, ISO, ISO/CE, ISO/FDA/CE, KC, Korean-FDA, MDEL, MHRA, NDA, NIH, NIOSH, NMPA, NMPA/CE, NMPA/CE/FDA-EUA/WHO-EUL/ANVISA/TGA, NMRC, NOISH, NQA, NRCS, PEUA FDA, PMPB, PPB, RFDA, RoHS, SABS, SAHPRA, SGS, SON, TGA, TMDA, UL, WHO, WHO PQS, ZAMRA

Incoterms

EXW

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Vendor Information

  • Store Name: LumiraDx
  • Vendor: LumiraDx
  • Address: LumiraDx UK Ltd., Unit 2 Block 6, Dumyat Business PARK, Alloa, FK10 2PB
    Scotland
    United Kingdom (UK)
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