Home / Clinical Laboratory / Controls / Quality Control / Antibody Test Quality Control Dimension Vista® / Dimension® EXL™ SARS-CoV-2 IgG Positive Level / Negative Level 6 X 2 X 1 mL11417773
Picture of Antibody Test Quality Control Dimension Vista® / Dimension® EXL™ SARS-CoV-2 IgG Positive Level / Negative Level 6 X 2 X 1 mL11417773

Antibody Test Quality Control Dimension Vista® / Dimension® EXL™ SARS-CoV-2 IgG Positive Level / Negative Level 6 X 2 X 1 mL11417773

Antibody-Test-Quality-Control-Dimension-Vista®--Dimension®-EXL™-SARS-CoV-2-IgG-Positive-Level--Negative-Level-6-X-2-X-1-mL11417773

SKU #

#1184492

MPN #

11417773

Brand

Siemens

Stock

In Stock

Quantity

100

Features

CONTROL, DIMENSION/VISTA COV2G/CV2G 6X2X1ML QC (12/KT) D/S

$178.80 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1184492
Manufacturer # 11417773
Brand Dimension Vista® / Dimension® EXL™
Manufacturer Siemens
Application Quality Control
Container Type Vial
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
Levels Positive Level / Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 30 days
Storage Requirements Keep Frozen
Test Name SARS-CoV-2 IgG
Test Type Antibody Test
UNSPSC Code 41116128
Volume 6 X 2 X 1 mL
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  • 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
  • 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
  • This product has been authorized only for detecting the presence of IgG antibodies against SARS‑CoV‑2, not for any other viruses or pathogens
  • 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
  • 6 x 1.0 mL positive quality control
  • 6 x 1.0 mL negative quality control