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Nucleic acid amplification mastermix reagent IVD

Definition
A reagent intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].
GUDID devices
7
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810096640055Biomeme SARS-CoV-2 Go-StripsBiomeme, Inc.12022-12-02
00810096640093Biomeme SARS-CoV-2 Go-PlatesBiomeme, Inc.12022-12-02
00382904428457BD MAX™ TNA MMKBECTON, DICKINSON AND COMPANY4428452024-02-20
10810096640052Biomeme SARS-CoV-2 Go-StripsBiomeme, Inc.12022-12-02
10810096640090Biomeme SARS-CoV-2 Go-PlatesBiomeme, Inc.12022-12-02
10814278020199NeuMoDxTM LDT Master Mix, DNANeumodx Molecular, Inc.2101002019-03-29
10814278020205NeuMoDxTM LDT Master Mix, RNANeumodx Molecular, Inc.3101002019-03-29