Laboratory Medicine AI medical devices
A neutral, evidence-based catalogue of laboratory medicine AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
23andMe, Inc.
Sourced from FDA AI listlaboratory_medicineTriVerity
Inflammatix, Inc.
Sourced from FDA AI listlaboratory_medicineX100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs , Ltd.
Sourced from FDA AI listlaboratory_medicineAPAS Independence with Urine Analysis Module
Clever Culture Systems AG
Sourced from FDA AI listlaboratory_medicinePhenoMATRIX
Copan Wasp Srl
Sourced from FDA AI listlaboratory_medicineAccelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc.
Sourced from FDA AI listlaboratory_medicineLensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Bonraybio Co., Ltd.
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes, Ltd.
Sourced from FDA AI listlaboratory_medicineVITEK MS
BIOMERIEUX, INC.
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes Ltd
Sourced from FDA AI listlaboratory_medicineLensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
Bonraybio Co., LTD.
Sourced from FDA AI listlaboratory_medicineFluChip-8G Influenza A+B Assay
InDevR, Inc.
Sourced from FDA AI listlaboratory_medicineLensHooke X12 PRO Semen Analysis System
Bonraybio Co., LTD.
Sourced from FDA AI listlaboratory_medicineAUTION EYE AI-4510 Urine Particle Analysis System
Arkray Inc.
Sourced from FDA AI listlaboratory_medicineAI100 with Shonit
SigTuple Technologies Pvt. Ltd.
Sourced from FDA AI listlaboratory_medicineMinuteful-kidney test
Healthy.io Ltd.
Sourced from FDA AI listlaboratory_medicineX100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs Ltd.
Sourced from FDA AI listlaboratory_medicineAthelas Home
Athelas Inc.
Sourced from FDA AI listlaboratory_medicineLensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
Bonraybio Co., Ltd.
Sourced from FDA AI listlaboratory_medicineCellaVision DC-1, CellaVision DC-1 PPA
CellaVision AB
Sourced from FDA AI listlaboratory_medicineX100 with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs LTD.
Sourced from FDA AI listlaboratory_medicineAthelas Home
Athelas, Inc.
Sourced from FDA AI listlaboratory_medicineSight OLO
Sight Diagnostics Ltd.
Sourced from FDA AI listlaboratory_medicineACR LAB Urine Analysis Test System
Healthy.io Ltd
Sourced from FDA AI listlaboratory_medicineAthelas One
Athelas Inc.
Sourced from FDA AI listlaboratory_medicineDIP/U.S. Urine Analysis Test System
Healthy.io Ltd
Sourced from FDA AI listlaboratory_medicineAdvanced RBC Application
Cella Vision AB
Sourced from FDA AI listlaboratory_medicineOne Drop Blood Glucose Monitoring System
AgaMatrix, Inc.
Sourced from FDA AI listlaboratory_medicineDario Blood Glucose Monitoring System
LabStyle Innovations Ltd.
Sourced from FDA AI listlaboratory_medicineUNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
BECKMAN COULTER, INC.
Sourced from FDA AI listlaboratory_medicineKidneyIntelX.dkd
Renalytix AI, Inc.
Sourced from FDA AI listlaboratory_medicineMALDI BIOTYPER CA (MBT-CA) SYSTEM
BRUKER DALTONICS, INC
Sourced from FDA AI listlaboratory_medicineCELLAVISION DM96 WITH THE BODY FLUID APPLICATION
CELLAVISION AB
Sourced from FDA AI listlaboratory_medicineCELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
CELLAVISION AB
Sourced from FDA AI listlaboratory_medicineEASYCELL CELL LOCATOR
MEDICA CORP.
Sourced from FDA AI listlaboratory_medicineCELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
CELLAVISION AB
Sourced from FDA AI listlaboratory_medicineDIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
CELLAVISION AB
Sourced from FDA AI list