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Access A30944 Automated Immunoassay Calibration Set
Laboratory / Clinical Analyzer, Reagent & Accessories / 1393986 | Beckman Coulter Corp - A30944
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Laboratory
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Clinical Analyzer, Reagent & Accessories
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Chemistry & Immunology
UNSPSC:
41116128
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Access Automated Immunoassay Calibration Set Ea
1393986
| Beckman Coulter Corp - A30944
Description:
Access Automated Immunoassay Calibration Set Each
Category:
Laboratory
/
Clinical Analyzer, Reagent & Accessories
UNSPSC:
41116128
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Product Overview
Product feature summary
Features & Benefits:
• This test has not been FDA cleared or approved
• This test has been authorized by FDA under an EUA for use by authorized laboratories
• This test has been authorized only for the presence of IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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
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Calibration Set
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Automated Immunoassay
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