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Nucleic acid amplification mastermix kit IVD

Definition
A collection of reagents and other associated materials 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
40
Last updated
2025-02-27 11:59:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858637005963DNA and LQAS Reagent SLIB Group KitEXACT SCIENCES CORPORATION1007292025-02-19
04053228049418QIAcuityDx® Universal MasterMix KitQIAGEN GmbH12024-09-30
04053228049432QIAcuityDx® Universal MasterMix KitQIAGEN GmbH12024-09-30
G257ASM000990Genomadix Cube CYP2C19Genomadix Inc22024-06-14
G257ASM001010Genomadix Cube CYP2C19Genomadix Inc22024-06-14
G257ASM001160Genomadix Cube CYP2C19Genomadix Inc22024-06-14
ASM00101Genomadix Cube CYP2C19,Genomadix Inc22023-07-18
10812125010058AcuitasOpgen, Inc.CP34022023-04-28
20812125010031AcuitasOpgen, Inc.KT03U01-22023-04-28
04260364751031AcuitasCuretis GmbHAcuitas AMR Gene Panel Reagent Kit2023-03-15
03661540952517MGB Alert 2X ELITaq Master Mix, 48rxnElitechgroup Mdx LLCM8008092023-02-03
03661540952524MGB Alert ELITaq Master Mix, 480 rxnElitechgroup Mdx LLCM8008102023-02-03
10810096640045Biomeme SARS-CoV-2 Go-Strips KitBiomeme, Inc.12022-12-02
10810096640083Biomeme SARS-CoV-2 Go-Plates KitBiomeme, Inc.12022-12-02
00812125010051AcuitasOpgen, Inc.CP34022021-10-25
01812125010036AcuitasOpgen, Inc.KT03U01-22021-10-06
00858637005451D CAL 1 KitEXACT SCIENCES CORPORATION1003042021-08-27
00858637005468D CAL 2 KitEXACT SCIENCES CORPORATION1003052021-08-27
00858637005475D CAL 3 KitEXACT SCIENCES CORPORATION1003062021-08-27
00858637005482D CAL 4 KitEXACT SCIENCES CORPORATION1003072021-08-27
00858637005499ENZ KitEXACT SCIENCES CORPORATION1003082021-08-27
00858637005505MIX A KitEXACT SCIENCES CORPORATION1003092021-08-27
00858637005512MIX B KitEXACT SCIENCES CORPORATION1003102021-08-27
00858637005529CAR SLN KitEXACT SCIENCES CORPORATION1003112021-08-27
00858637005536ELU BFR KitEXACT SCIENCES CORPORATION1003122021-08-27
03661540950278MGB Alert Platinum Master Mix-48 rxnElitechgroup Mdx LLCM8005992020-09-15
03661540951725MGB Alert 2X PCR Master Mix 480 rxnElitechgroup Mdx LLCM8005472020-09-15
03661540951756MGB Alert One-Step Reverse Transcriptase PCR Master Mix Elitechgroup Mdx LLCM8006892020-09-15
03661540951787MGB Alert 2X PCR Master Mix 48 rxnElitechgroup Mdx LLCM8003312020-09-15
03661540951794MGB Alert Platinum Master Mix, 09N41-005Elitechgroup Mdx LLCM800599-am2020-09-15
03661540951800MGB Alert Platinum Master Mix-480rxnElitechgroup Mdx LLCM8006912020-09-15
03661540951817MGB Alert Platinum Master Mix, with water-48rxnElitechgroup Mdx LLCM800693 2020-09-15
03661540951824MGB Alert Platinum Master Mix with water-480rxnElitechgroup Mdx LLCM8006942020-09-15
03661540950193MGB Alert PCR Master Mix 09N41-004Elitechgroup Mdx LLCM800331-am2020-09-14
10814278020304NeuMoDxTM LDT Probe/Primer StripNeumodx Molecular, Inc.1004002019-03-29
00858637005048Cologuard QuARTS Assay ReagentsEXACT SCIENCES CORPORATION1000302014-11-17
00875197005561cobas omni Utility Channel Reagent KitRoche Diagnostics GmbH075572721902017-09-29
00628055420088Spartan RX CYP2C19 SystemSpartan Bioscience Inc01004872-ABC2016-09-26
00628055420095Spartan RX CYP2C19 SystemSpartan Bioscience Inc01004880-ABC (10)2016-09-26
00628055420101Spartan RX CYP2C19 SystemSpartan Bioscience Inc01004880-ABC (20)2016-09-26