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Continuing with these efforts, CLC distributes PCR and Extraction Instruments additional to their COVID-19 product offering. This includes the 3DMed ANDiS 380, which is a high-yield automated nucleic acid extraction system with a 96-well extractor. This instrument can run 96 extractions in 40 minutes and has an extremely high extraction efficiency, with a >95% recovery rate of magnetic beads.
CLC provides the Azure Cielo™ 6, a 96-Well Real-Time PCR System designed to be user-friendly with a large touch screen interface and software compatible with LIMS. The Azure Cielo™ 6 also contains optics and thermal blocks designed to deliver the same uniformity and reproducibility for high-throughput testing.
CLC also offers FDA Emergency Use Authorized Real-Time RT-PCR Test Kits. The QuantiVirus™ SARS-CoV-2 Test Kits from DiaCarta are based on real-time Reverse-Transcription Polymerase Chain Reaction (RT-PCR) technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal, and sputum samples.
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Most notably, CLC offers the Point-of-Care/CLIA-Waived/Fingerstick Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech. This test has received FDA Emergency Use Authorization for use with fingerstick whole blood specimens at the point-of-care, i.e. in patient care settings operating under CLIA Certificate of Waiver such as doctor's offices, hospitals, urgent care centers, pharmacies, university health centers, and emergency rooms rather than having to be sent to a central lab. For all CLC COVID-19 products, please refer to www.carolinachemistries.com for instructions for use, fast facts for healthcare providers and patients, and EUA information.
All Emergency Use Authorized tests are authorized for the intended use provided by the FDA in the EUA; these EUAs can be found at www.carolinachemistries.com. These tests have not been FDA cleared or approved. Tests are 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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About Carolina Liquid Chemistries Corp.
Headquartered in Greensboro, NC, Carolina Liquid Chemistries Corp. (CLC) is an authorized manufacturer, re-packager, re-labeler and value-added distributor of chemistry systems and reagents, as well as COVID-19 testing supplies. CLC helps clinical laboratories of all sizes reduce chemistry analyzer and reagent costs, while also receiving accurate and timely results. The company has responded to the COVID-19 pandemic by bringing several PCR and antibody tests to market under the FDA's Emergency Use Authorization. For more information, visit carolinachemistries.com or email [email protected].
SOURCE Carolina Liquid Chemistries
Filed Under: Business
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