NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE

EMDN W0104080606

Parent W01040806 NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY)

Registry term list. Not a clinical opinion. 41 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
Carbapenem Resistance Detection Kit (24)	08684190150732	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem Resistance Detection Kit (24)	08684190152057	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem Resistance Detection Kit (24)	08684190153313	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)	06974849369649	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)	06974849369656	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)	06974849369663	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)	06974849369670	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)	06974849369687	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
CRE 16-well	09343044002199	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
CRE 16-well	09343044002205	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
CRE EU 16-well	09343044002649	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
CRE EU 16-well	09343044002656	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
CRE Reference 24-well	09343044004735	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
CRE Reference 24-well	09343044004742	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
eazyplex® SuperBug Acineto	04250592376076	AmplexDiagnostics GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
eazyplex® SuperBug basic	04250592376038	AmplexDiagnostics GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
eazyplex® SuperBug complete A	04250592376014	AmplexDiagnostics GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
eazyplex® SuperBug complete B	04250592376021	AmplexDiagnostics GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
eazyplex® SuperBug complete C	04250592376083	AmplexDiagnostics GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
eazyplex® SuperBug expert	04250592376090	AmplexDiagnostics GmbH	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
EntericBio ® CPE	05391513879272	Serosep Limited	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MicroMDx Carbapenem resistance gene Cartridge PCR Assay	06930317812888	Dynamiker Biotechnology (Tianjin) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MicroMDx Carbapenem resistance gene Cartridge PCR Assay	06930317829640	Dynamiker Biotechnology (Tianjin) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Multiple Real-Time PCR Detection Kit for Carbapenem-resistant Gene	06974323011552	Beijing Applied Biological Technologies Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Multiple Real-Time PCR Detection Kit for Carbapenem-resistant Gene	06974323011569	Beijing Applied Biological Technologies Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MycoMDx Carbapenem resistance gene Assay (F-PCR)	06930317888319	Dynamiker Biotechnology (Tianjin) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
MycoMDx Carbapenem resistance gene Assay (F-PCR)	06930317892651	Dynamiker Biotechnology (Tianjin) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Nucleic Acid Extraction or Purification Reagent	16975631347019	JIANGSU COMEON MEDICAL APPARATUS CO., LTD	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Nucleic Acid Extraction or Purification Reagent	16975631347026	JIANGSU COMEON MEDICAL APPARATUS CO., LTD	Class A	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
RIDA®Plex CRE 16 well Step 1	09343044006449	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
RIDA®Plex CRE 16 well Step 2	09343044006432	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
RIDA®Plex CRE EU 16 well Step 1	09343044006463	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
RIDA®Plex CRE EU 16 well Step 2	09343044006456	AusDiagnostics Pty Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
TRUPCR® Carbapenem Resistance Detection Kit	08906213930337	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
TRUPCR® Carbapenem Resistance Detection Kit	08906213930344	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
TRUPCR® Carbapenem Resistance Detection Kit	08906213930351	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
U-CardDx™ 200	06933289854054	Guangzhou Wondfo Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Xpert®	07332940001049	Cepheid	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Xpert®	07332940002015	Cepheid	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Xpert®	07332940006518	Cepheid	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Xpert®	07332940006525	Cepheid	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED