Product Overview
Manufacturer
- LUMIRADX INC
Features
- 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
- Product ships from McKesson with minimum 30 days dating
- 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
- 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 with other viruses
- 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 Food, Drug and Cosmetic Act, 21 U.S.C. ? 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
- 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
- The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2
Attributes
- Application: Respiratory Test Kit
- Contents 1: (48) Individually Packed Test Strips, LumiraDx Test Product Insert, RFID Tag, Dropper Lids, Quick Reference Instructions
- For Use With: For use with the LumiraDx Platform
- Is_Active_Vendor: Y
- Is_DSCSA: N
- Is_Discontinued: N
- Is_Medical_Device: N
- Lot_Tracking_Flag: Y
- Number of Tests: 48 Tests
- On_Allocation: N
- Product Dating: McKesson Acceptable Dating: we will ship >= 30 days
- Purchase Program Type: Standard Purchase
- Reading Type: Machine Read
- Sample Type: Nasal Swab Sample
- Specialty: Immunoassay
- Supplier_ID: 67246160
- Test Format: Test Strip Format
- Test Kit Type: Rapid
- Test Method: Rapid Microfluidic Immunofluorescence Assay
- Test Name: SARS-CoV-2 Ag
- Test Type: Antigen Test
- Time to Results: 12 Minute Results
- UNSPSC Code: 41116127
