Antibody Test Quality Control Dimension Vista / Dimension EXL SARS-CoV-2 IgG Positive Level / Negative Level 6 X 2 X 1 mL
- This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations \n
- Limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests \n
- This product has been authorized only for detecting the presence of IgG antibodies against SARS?CoV?2, not for any other viruses or pathogens \n
- The emergency use of this product 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. 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner \n
- 6 x 1.0 mL positive quality control \n
- 6 x 1.0 mL negative quality control
- Manufacturer #:
- 11417773
- UNSPSC:
- 41116128
- Storage requirements:
- keep frozen
- Volume:
- 6 x 2 x 1 ml
- Test type:
- antibody test
- Brand:
- Dimension Vista / Dimension Exl
- Levels:
- positive level / negative level
- Application:
- quality control
- Product dating:
- mckesson acceptable dating: we will ship >= 30 days
- Manufacturer:
- Siemens Healthcare
- Test name:
- sars-cov-2 igg
- Mckesson #:
- 1184492
- For use with:
- for monitoring the accuracy of the sars?cov?2 igg antibody assay on the dimension vista system and the dimension exl integrated chemistry system with loci module
- Container type:
- vial
