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. 494 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
Nucleic Acid Release Reagent	16974900602026	Zhuhai Shineway Biotech Co.,Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Palm Fluorescent PCR Analyzer	26974900600173	Zhuhai Shineway Biotech Co.,Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
PCR Nucleic Acid Analyzer	06974900600018	Zhuhai Shineway Biotech Co.,Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
PGDx elio tissue complete	00192721001470	Personal Genome Diagnostics, Inc.	Class C	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
PGDx elio tissue complete	00192721001487	Personal Genome Diagnostics, Inc.	Class C	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Pluslife Dock Pro 8	06975327120172	Guangzhou Pluslife Biotech Co., Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
PoET Instrument	04262353370162	Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Molecular Diagnostic System	06955792700000	Sansure Biotech Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Molecular Diagnostic System	06955792700048	Sansure Biotech Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Molecular Workstation	06955792730472	Sansure Biotech Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Molecular Workstation	06955792730496	Sansure Biotech Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Molecule Workstation	06955792731301	Sansure Biotech Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Molecule Workstation	06955792731318	Sansure Biotech Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Nucleic Acid Detection Instrument	06975275770146	Suzhou Molarray Co., Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Portable Nucleic Acid Testing Box	06975275770139	Suzhou Molarray Co., Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
PRIME MDX	08059575111729	MASMEC SpA	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Procleix Panther System	00850032683609	Grifols Diagnostic Solutions Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
PsorX-LabDisk	04262367270014	Dermagnostix GmbH	Unknown class	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAcuityDx Four	04053228048770	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAstat-Dx Analytical Module	04053228033929	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAstat-Dx Operational Module	04053228033936	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAstat-Dx Operational Module PRO	04053228047582	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAstat-Dx Rise	04053228041849	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAsymphony AS	04053228010746	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAsymphony Connect	04053228049982	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QIAsymphony SP	04053228010739	QIAGEN GmbH	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QuantFlex Fluorometer	06973843221496	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QuantGene 9600 Fluorescent Quantitative Detection System	06973843220628	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QuantGene 9600 Fluorescent Quantitative Detection System	06973843220635	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QuantGene 9600 Fluorescent Quantitative Detection System	06973843220642	Hangzhou Bioer Technology Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Quantitative Real-time PCR System	06941967205173	Zybio Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Quantitative Real-time PCR System	06941967205180	Zybio Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Quantitative Real-time PCR System	06941967205197	Zybio Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Quantitative Real-time PCR System	06941967205203	Zybio Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Quantitative Real-time PCR System	06973262866124	Zybio Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QuantStudio™ 5 Dx Real‑Time PCR Instrument (96-Well 0.2ml Block)	10190302015592	Life Technologies Holdings Pte Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument	10190302016148	Life Technologies Holdings Pte Ltd	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
RADIONE 4ch	08800204301888	KH Medical Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
RADI PCR 96 PLUS	08800204300690	KH Medical Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Rapid Detection System	06928103081303	Daan Gene Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-Prep	08809886490033	HANWOOLTPC Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time fluorescence quantitative PCR analyzer	06976045290024	Chongqing ME Instruments Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-Time Fluorescence Quantitative PCR System	06973315738491	Nanjing Vazyme Medical Technology Co.,Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time PCR	06975488440942	Infitek Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time PCR Detection System	06928103081204	Daan Gene Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time PCR Instrument	06975600660005	Guangdong RunPon Bioscience Inc.	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time PCR instrument DTlite 4S1	04660014360512	DNA-Technology, Research & Production, LLC	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time PCR instrument DTlite 5S1	04660014360529	DNA-Technology, Research & Production, LLC	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time PCR instrument DTprime 4M1	04660014360505	DNA-Technology, Research & Production, LLC	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED
Real-time PCR instrument DTprime 4М3	04660014362370	DNA-Technology, Research & Production, LLC	Class A	No Certificate Found Snapshot 2026-10-17 · Link to EUDAMED