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VIS-L01-US01-SB002 |

Respiratory Test Kit LumiraDx™ SARS-CoV-2 Ag 48 Tests X 5 Kits CLIA Waived

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About this item

  • The LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization ONLY: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate, high or waived complexity tests
  • This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • Starter Pack includes: 1198202 Instrument V5E including Connect Manager, 1197690 SARS-CoV-2 Ag Test Strip (48 Tests/Kit), 1197712 SARS-CoV-2 Ag Liquid Control, 1198198 Barcode Scanner, 1198199 Printer, 1197991 SteriPack™ Sterile Polyester Spun Swab (
  • The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2
  • Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in nasal swab specimens during the acute phase of infection
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection
  • Negative results, from patients with symptoms onset beyond twelve days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
  • Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
  • Negative results should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19
  • The LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Foo
  • The workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result in under 12 minutes from sample application
  • Price: Available Upon Quote

    50+ In Stock.

    STARTER PACK, LUMIRADX PLATFORM D/S
    Product Specifications:
    Manufacturer #: L01-US01-SB002
    Brand: LumiraDx™
    Manufacturer: LumiraDx Inc
    Country of Origin: Unknown
    Application: Respiratory Test Kit
    CLIA Classified: CLIA Waived
    Contents 1: Starter Pack includes: (1) LumiraDx Instrument, (1) Barcode Scanner, (1) Printer, (5) SARS-CoV-2 Test Strip Kits with (48) Tests per Kit, (1) SARS-CoV-2 Ag Liquid Control, (6) Boxes Steripack™ Sterile Polyester Spun Swabs (25 Swabs per Box)
    For Use With: For use with the LumiraDx Platform
    Number of Tests: 48 Tests X 5 Kits
    Product Dating: McKesson Acceptable Dating: we will ship >= 90 days
    Purchase Program Type: Starter Kit
    Reading Type: Machine Read
    Sample Type: Nasal Swab Sample
    Specialty: Immunoassay
    Test Format: Test Strip Format
    Test Kit Type: Rapid
    Test Method: Microfluidic Immunofluorescence Assay
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    Please note that product and satisfaction concerns must be brought to our team's attention within (1) one-year from the date of purchase or within 50% of product usage (usually found in Printer Settings). Concerns made known after the one-year period will be issued store credit. We must receive the items being returned before we issue a refund or store credit.

    Below you will find our most frequently asked questions. If you have any additional questions or feedback, please do not hesitate to contact us.

    • What is a compatible ink cartridge?
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      MAGNUSON-MOSS WARRANTY IMPROVEMENT ACT

      United States Code Annotated

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      Section 2302 (c)

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