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Molecular grade lysis reagent IVD

Definition
A substance or reactant containing a protein denaturant (e.g., guanidine thiocyanate) intended to be used alone or in combination with other IVDs for the extraction of nucleic acids (e.g., DNA, RNA) from cells in a clinical specimen in preparation for further analysis using a nucleic acid technique (NAT).
GUDID devices
6
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10814278020861NeuMoDx™ Lysis Buffer 5Neumodx Molecular, Inc.4009002021-12-13
10814278021301NeuMoDx™ Vantage Viral Lysis BufferNeumodx Molecular, Inc.4015002021-12-13
04053228003526QIAGEN Buffer ASL®QIAGEN GmbH12024-09-30
00884999047877Alinity mABBOTT MOLECULAR INC.09N20-0012020-06-10
00814278020864NeuMoDx™ Lysis Buffer 5Neumodx Molecular, Inc.4009002021-12-13
00814278021304NeuMoDx™ Vantage Viral Lysis BufferNeumodx Molecular, Inc.4015002021-12-13