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PCR/NAT negative control IVD

Definition
A material or solution, known to give a negative result, intended to be used to verify the performance and/or identify contamination, or non-specific amplification in a qualitative and/or quantitative assay performed on a clinical specimen using a nucleic acid technique (NAT) or polymerase chain reaction (PCR).
GUDID devices
27
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10190302000888Ion TorrentLIFE TECHNOLOGIES CORPORATIONA303202018-06-28
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0081NS2024-09-04
03610522384372Exact DiagnosticsEXACT DIAGNOSTICS, LLC120200682024-08-27
00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbH090519531902024-06-05
03610522350773Exact DiagnosticsEXACT DIAGNOSTICS, LLC120194322023-05-09
10812125010041AcuitasOpgen, Inc.CP32332023-04-28
00850032683005Procleix HIV-1/HCV/HBV Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.HIV-1/HCV/HBV Negative Control2023-02-15
00850032683043Procleix WNV/Babesia Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.WNV/Babesia Negative Control2023-02-15
10634853001210Inocu SwabsMICROBIOLOGICS INC.CE VRE-022022-09-26
10634853001272Inocu SwabsMICROBIOLOGICS INC.GBS-022022-09-26
10634853001296Inocu SwabsMICROBIOLOGICS INC.MRSA-022022-09-26
10634853001302Inocu SwabsMICROBIOLOGICS INC.MSSE-012022-09-26
00875197006445cobas® NHP Negative Control KitRoche Molecular Systems, Inc.090515541902022-08-01
00812242031137Exact DiagnosticsEXACT DIAGNOSTICS, LLCNEGSYN2022-06-17
00812242031144Exact DiagnosticsEXACT DIAGNOSTICS, LLCNEGHAI2022-06-17
00812125010044AcuitasOpgen, Inc.CP32332021-10-25
10845357043594Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0067NS2020-12-17
10845357043624Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0058-DN2020-12-17
10190302006156Ion Torrent™ Dx No Template Control KitLIFE TECHNOLOGIES CORPORATIONA324442017-06-27
00884883007543MAS Infectious Negative ControlMicrogenics Corporation100274842020-06-30
10845357043273Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0058N2020-04-30
00875197005127cobas® NHP Negative Control KitRoche Diagnostics GmbH1.02015-12-04
00875197005134cobas&#x00AE Buffer Negative Control KitRoche Diagnostics GmbH070022381902017-09-29
00884883005945AcroMetrix BB NAT Negative ControlMicrogenics Corporation9636002016-09-22
00884883006447Acrometrix Negative ControlMicrogenics Corporation962000A2018-06-12
00812242030062Exact DiagnosticsEXACT DIAGNOSTICS, LLCNEG0002018-09-24
00812242030079Exact DiagnosticsEXACT DIAGNOSTICS, LLCNEG0502018-09-24