Calibrator Kit Vitros SARS-CoV-2 Antigen 2 X 1 mL For use with Vitros SARS-CoV-2 Antigen Test / For use on the VITROS 3600 Immunodiagnostic System and the VITROS 5600 / XT 7600 Integrated Systems Liquid
- The Vitros SARS-CoV-2 Antigen Reagent Pack used in combination with the Vitros SARS-CoV-2 Antigen Calibrator is for use under an FDA EUA only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations \n
- Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests \n
- EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act \n
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health laboratories \n
- Negative results from patients with symptom onset outside of one to six days should be treated as presumptive \n
- 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 \n
- Negative results should be considered in the context of a patient?s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 \n
- 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 \n
- Includes: 2 vials of VITROS SARS-CoV-2 Antigen Calibrator (recombinant SARS-CoV-2 nucleocapsid antigen in buffer with bovine serum albumin and antimicrobial agent, 1.0 mL) and 8 calibrator bar code labels
- Volume:
- 2 x 1 ml
- Manufacturer:
- Ortho Clinical Diagnostics
- Test name:
- sars-cov-2 antigen
- Manufacturer #:
- 6199950
- Application:
- calibrator kit
- UNSPSC:
- 41116128
- Mckesson #:
- 1180546
- Brand:
- Vitros
- For use with:
- for use with vitros sars-cov-2 antigen test / for use on the vitros 3600 immunodiagnostic system and the vitros 5600 / xt 7600 integrated systems
- Product dating:
- mckesson acceptable dating: we will ship >= 90 days
- Storage requirements:
- keep frozen
- Container type:
- vial
- Form:
- liquid
- Levels:
- 1 level