NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS

EMDN W02050116

Parent W020501 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS

Registry term list. Not a clinical opinion. 491 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
HighPrep PCR - DX (1 mL)	00850045030650	MagBio Genomics, Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HighPrep PCR - DX (250 mL)	00850045030148	MagBio Genomics, Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HighPrep PCR - DX (500 mL)	00850045030155	MagBio Genomics, Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HighPrep PCR - DX (50 mL)	00850045030131	MagBio Genomics, Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HighPrep PCR - DX (5 mL)	00850045030124	MagBio Genomics, Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Idylla™ Console	05415219000126	Biocartis NV	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Idylla™ Hub	05415219001390	Biocartis NV	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Idylla™ Instrument	05415219000119	Biocartis NV	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Integrated Digital PCR Instrument	06975578360280	Pilot Gene Technology (Hangzhou) Co., Ltd	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Ion OneTouch™ ES Dx Instrument	10190302000864	Life Technologies Holdings Pte Ltd	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Ion PGM™ Dx Sequencer	10190302000833	Life Technologies Holdings Pte Ltd	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
IRON-qPCR™	08809537070744	BIONEER Corporation	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
isoQuarkF2	08800122900002	RevoSketch Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
isoQuarkM4	08800122900064	RevoSketch Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Katsura Biological Coporation	04719883180018	Katsura Biological Corp	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Kingwell Automated Thermal Cycler	06974149860051	Aperbio Technologies (Suzhou) Co., Ltd	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Lab-Aid 808 Nucleic Acid Extraction System	06956299702078	Xiamen Zeesan Biotech Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Lab-Aid 824s Nucleic Acid Extraction System	06956299702092	Xiamen Zeesan Biotech Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Lab-Aid 960 Nucleic Acid Extraction System	06956299702085	Xiamen Zeesan Biotech Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Liferiver Intelligent Molecular Mobile Mini-Lab	06974613760160	Shanghai ZJ Bio-Tech Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Plus Fluorescent Quantitative Detection System	06973843220765	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Plus Fluorescent Quantitative Detection System	06973843220772	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Plus Fluorescent Quantitative Detection System	06973843220789	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Plus Fluorescent Quantitative Detection System	06973843220796	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Pro Fluorescenct Quantitative Detection System	06973843221304	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Pro Fluorescenct Quantitative Detection System	06973843221311	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Pro Fluorescenct Quantitative Detection System	06973843221328	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene 9600 Pro Fluorescenct Quantitative Detection System	06973843221335	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene K Plus Fluorescent Quantitative Detection System	06973843221243	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene K Plus Fluorescent Quantitative Detection System	06973843221250	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene Mini Fluorescent Quantitative Detection System	06973843221212	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene Mini Fluorescent Quantitative Detection System	06973843221229	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene Mini Fluorescent Quantitative Detection System	06973843221236	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene MiniS Fluorescent Quantitative Detection System	06973843220710	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LineGene MiniS Fluorescent Quantitative Detection System	06973843220727	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LOAA Analyzer	08809740940025	OPTOLANE Technologies Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LOAA-M Console	08809740940063	OPTOLANE Technologies Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LOAA-M Module	08809740940070	OPTOLANE Technologies Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LOAA-M POWERBOX	08809740940117	OPTOLANE Technologies Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LOAA-M Powerbox System	08809740940124	OPTOLANE Technologies Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Logilet Logicore System	06973315734936	Nanjing Vazyme Medical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16-Flex Genomic DNA Purification Kit From Bacteria	08684595034644	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16-Flex Genomic DNA Purification Kit From Bacteria	08684595034651	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16-Flex Genomic DNA Purification Kit From Blood	08684595034521	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16-Flex Genomic DNA Purification Kit From Blood	08684595034538	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16-Flex Total Nucleic Acid Purification Kit	08684595032220	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16-Flex Total Nucleic Acid Purification Kit	08684595034422	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16 Genomic DNA Purification Kit from Bacteria	08684595034620	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16 Genomic DNA Purification Kit from Bacteria	08684595034613	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MagFast 16 Genomic DNA Purification Kit From Blood	08684595034491	Vitrosens Biotechnology Inc.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED