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FDA 510(k), K200065, cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
FDA 510(k), K200065, cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
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$149.00 USD
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$149.00 USD
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510(K) Number: K200065
Device Name: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
Manufacturer: Kaitlyn Hameister
Device Classification Name: Respiratory Virus Panel Nucleic Acid Assay System
Regulation Number: OCC
Classification Product Code: 01/13/2020
Date Received: 02/10/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
Manufacturer: Kaitlyn Hameister
Device Classification Name: Respiratory Virus Panel Nucleic Acid Assay System
Regulation Number: OCC
Classification Product Code: 01/13/2020
Date Received: 02/10/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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