Diazyme DZ-Lite SARS-CoV-2 IgG and IgM Automated Antibody CLIA Test Kits for DZ‑Lite 3000 Plus

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FDA Emergency Use Authorization Granted

CLC offers COVID-19 testing solutions for clinical laboratories

Carolina Liquid Chemistries now offers the FDA Emergency Use Authorized Diazyme DZ-Lite SARS-CoV-2 IgG and IgM Automated Antibody CLIA Assays on the DZ-Lite 3000 Plus Chemiluminescence Immunoassay Analyzer

Carolina Liquid Chemistries now offers the Diazyme DZ-Lite SARS-CoV-2 IgG and IgM CLIA Kits for use on the DZ-Lite 3000 Plus fully automated chemiluminescence immunoassay system.

These kits have been granted FDA Emergency Use Authorization and can be performed by 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.

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DZ-Lite™ 3000 Plus

Fully Automated Chemiluminescence Immunoassay System

DZ-Lite 3000 Plus Chemiluminescence Immunoassay System (CLIA)

IgG Kit (EUA Granted) Details

  • Intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA, disodium EDTA and lithium heparin) using the DZ-lite 3000 Plus Chemiluminescence Analyzer.
  • Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
  • Part Number: DZ130219015M
  • Tests per kit: 100
  • For the detection of IgG antibodies against SARS-CoV-2
  • Sample Types: Serum, Plasma
  • Each kit contains:
    • Magnetic Microbeads 2.5 mL
    • ABEI Label 23.5 mL
    • Diluent 23.5 mL
    • Buffer 23.5 mL
    • Negative Control 1.0 mL
    • Positive Control 1.0 mL
    • Calibrator Low 1.0 mL
    • Calibrator High 1.0 mL

IgG Kit Important Documents

IgM Kit (EUA Granted) Details

  • Intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA, disodium EDTA and lithium heparin) using the DZ-lite 3000 Plus Chemiluminescence Analyzer.
  • Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
  • Part Number: DZ130219016M
  • Tests per kit: 100
  • For the detection of IgM antibodies against SARS-CoV-2
  • Sample Types: Serum, Plasma
  • Each kit contains:
    • Magnetic Microbeads 2.5 mL
    • ABEI Label 23.5 mL
    • Diluent 23.5 mL
    • Buffer 23.5 mL
    • Negative Control 1.0 mL
    • Positive Control 1.0 mL
    • Calibrator Low 1.0 mL
    • Calibrator High 1.0 mL

IgM Kit Important Documents

Important Information

The Diazyme DZ-Lite SARS-CoV-2 IgG and IgM CLIA Kits have not been FDA cleared or approved; these tests have been authorized by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform moderate or high complexity tests. The Diazyme DZ-Lite SARS-CoV-2 IgG and IgM CLIA Kits have been authorized only for the presence of IgM and IgG antibodies, respectively, against SARS-CoV-2, not for any other viruses or pathogens. These tests are 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.