FDA.reportPublic FDA data

Laboratory instrument/analyser application software IVD

Definition
An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).
GUDID devices
251
Last updated
2026-10-06 03:49:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.20262026-09-25
00380740223724AlinityAbbott GmbH06T793A2026-09-04
00380740225575ARCHITECTABBOTT LABORATORIES04P55312026-08-22
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLdIFine ANA HEp-2 Classifier2024-11-08
08059304340222dIFine DNA ClassifierVISIA LAB SRLdIFine DNA Classifier2024-11-08
08059304340239dIFine ANCA ClassifierVISIA LAB SRLdIFine ANCA Classifier2025-06-27
00884999051928Alinity mABBOTT MOLECULAR INC.09N15-03C2026-07-27
00380740186524AlinityAbbott GmbH04U001A2025-10-24
00380740194765AlinityAbbott GmbH04W211A2025-10-14
00380740195205AlinityAbbott GmbH07P885A2023-01-06
00380740195458AlinityAbbott GmbH07P701C2022-09-16
00380740202231ARCHITECTABBOTT LABORATORIES04P55242022-09-16
00380740202248ARCHITECTABBOTT LABORATORIES04P57262022-09-16
00380740202736AlinIQABBOTT SRL03R89632022-12-30
00380740204082ARCHITECTABBOTT LABORATORIES04P55252023-01-06
00380740214487ARCHITECTABBOTT LABORATORIES04P57302024-07-11
00380740223700ARCHITECTABBOTT LABORATORIES04J62272025-11-08
00380740223717ARCHITECTABBOTT LABORATORIES08G98272025-11-08
00380740225186ARCHITECTABBOTT LABORATORIES04P55302026-05-14
00380740225193ARCHITECTABBOTT LABORATORIES04P57332026-05-14
00884999051287Alinity mABBOTT MOLECULAR INC.09N15-03B2026-04-13
03607450000030STA Coag Expert®DIAGNOSTICA STAGOV82022-12-09
03607450000047Coag.One server licenseDIAGNOSTICA STAGOV82022-12-09
03607450867657Coag.One server licenseDIAGNOSTICA STAGOV72022-12-09
03607450871111STA Coag Expert®DIAGNOSTICA STAGOV72022-12-09
03610522136421IH-AbIDBio-Rad Medical Diagnostics GmbH120109022022-12-13
04049016068785EUROLineScanEUROIMMUN Medizinische Labordiagnostika AGYG 0006-01012022-12-08
04049016068815EUROPictureEUROIMMUN Medizinische Labordiagnostika AGYG 0011-01012022-12-08
04049016135210EUROLabOffice 4.0EUROIMMUN Medizinische Labordiagnostika AGYG 0250-0101-72022-12-08
04049016148708EUROPattern ClassifierEUROIMMUN Medizinische Labordiagnostika AGYG 0071-01012022-12-08
07350040977194CellaVision® Remote Review Single EditionCellavision ABCRRS-SI00992026-05-08
09120052070941USB-STICK MAGELLAN PRO V 7.3Tecan Austria GmbH30141795 002020-01-07
09120052071092USB-STICK MAGELLAN PRO V7.4Tecan Austria GmbH30185384 00 2021-01-07
09120052071238USB-STICK MAGELLAN V 7.5 SUNRISE+F50Tecan Austria GmbH30204301 002022-05-26
09120052071320USB-STICK MAGELLAN PRO V7.5Tecan Austria GmbH30219868 002023-02-26
10888234500858MatchXIMMUCOR GTI DIAGNOSTICS, INC.8886282025-09-30
B141MEDISSUITEMRCT20190Medis Suite MRCTMedis Medical Imaging Systems B.V.20192020-01-28
B141MEDISSUITEMRCT300Medis Suite MRCTMedis Medical Imaging Systems B.V.3.02017-08-07
B141QIVUS300QIvusMedis Medical Imaging Systems B.V.3.02026-04-21
G725QFR300QFRQFR Solutions B.V.3.02026-05-11
G725QFR310QFRQFR Solutions B.V.3.12026-05-11
00380740225155ARCHITECTABBOTT LABORATORIES04J62282026-01-03
00380740225162ARCHITECTABBOTT LABORATORIES08G98282026-01-03
00380740223748AlinityAbbott GmbH09P261D2026-01-01
00380740224523ARCHITECTABBOTT LABORATORIES04P55282026-01-01
00380740224530ARCHITECTABBOTT LABORATORIES04P57322026-01-01
00380740186241AlinityAbbott GmbH04T991A2025-12-19
00380740186258AlinityAbbott GmbH04T993A2025-12-19
00380740213398AlinityAbbott GmbH04T851B2025-12-19
00380740213404AlinityAbbott GmbH04T855B2025-12-19
00380740213411AlinityAbbott GmbH04T853B2025-12-19
00380740213428AlinityAbbott GmbH04T857B2025-12-19
04049016126034EUROArrayScanEUROIMMUN Medizinische Labordiagnostika AGYG 0621-01012025-12-19
00380740199074AlinityAbbott GmbH04W021A2025-11-27
00884999052062Alinity mABBOTT MOLECULAR INC.09N61-03B2025-11-20
00380740215224AlinityAbbott GmbH06T321A2025-09-29
00380740220556ARCHITECTABBOTT LABORATORIES04P55272025-08-22
00380740220563ARCHITECTABBOTT LABORATORIES04P57312025-08-22
10190302018883Ion Torrent Genexus Dx SoftwareLIFE TECHNOLOGIES HOLDINGS PTE. LTD.6.82025-07-24
00860012592500PathPresenter Clinical ViewerPathPresenter, Corporation1.02025-08-11
00380740220495ARCHITECTABBOTT LABORATORIES08G98262025-08-02
00380740220501ARCHITECTABBOTT LABORATORIES04J62262025-08-02
15420045517097DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.ASSEMBLY, REVIEW STATION COMPUTER2025-07-17
00884999049383Alinity mABBOTT MOLECULAR INC.09N79-03A2025-06-27
00884999050945Alinity mABBOTT MOLECULAR INC.09N85-05A2025-05-30
05414470156870LiRAS for LiPA HCV v1Fujirebio Europe156872025-05-30
B141MEDISSUITEMRCT20250Medis Suite MRCTMedis Medical Imaging Systems B.V.20252025-05-14
00884999051065Alinity mABBOTT MOLECULAR INC.09N46-05B2024-02-22
00860006054595Concentriq AP-DxProscia Inc.DX040US2025-05-08
10190302019859Diomni™ Software, Version 4.2.0LIFE TECHNOLOGIES HOLDINGS PTE. LTD.A400023232025-05-02
00380740216658AlinIQABBOTT SRL03R89672025-04-30
00380740186425AlinityAbbott GmbH04T881A2025-04-15
00380740190644ARCHITECTABBOTT LABORATORIES04S921A2025-04-15
00380740190651ARCHITECTABBOTT LABORATORIES04S923A2025-04-15
00380740201982AlinityAbbott GmbH07P475A2025-04-08
00380740216085AlinityAbbott GmbH04S793A2025-04-09
15420045517585DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.ASSEMBLY, REVIEW STATION COMPUTER2025-04-03
00858637005840Analysis Server v2.2EXACT SCIENCES CORPORATION2.22025-03-19
00858637005857Analysis Client v2.2EXACT SCIENCES CORPORATION2.22025-03-19
00858637005864STARlet Interface v2.2EXACT SCIENCES CORPORATION2.22025-03-19