Pathogen Nucleic Acid Detection Kits

Nucleic acid detection devices for bacterial, viral, fungal and parasitic pathogens, supplied in two formats: a non-fluorescent format (45 devices) and a fluorescent PCR format (45 devices) — 90 devices in total, all listed in the Notified Body confirmation letter.

EU regulatory status

165 devices listed in the Notified Body confirmation letter (TÜV Rheinland, NB 0197, 2026-07-10) under Regulation (EU) 2024/1860 — transition to 2028-12-31 (Class C) / 2029-12-31 (Class B).

The confirmation letter records the IVDR application and the signed written agreement, and sets out the transitional arrangements under Regulation (EU) 2024/1860. It is not an IVDR certificate, a CE certificate or an EU Declaration of Conformity, and it does not exempt any device from the remaining conformity assessment steps.

Non-fluorescent format — 45 devices

#	Device name	Basic UDI-DI	IVDR class
1	Vibrio cholerae Nucleic Acid Detection Kit	`697994388Nc001Z9`	Class C
2	Yellow Fever Virus Nucleic Acid Detection Kit	`697994388Nc002ZB`	Class C
3	Poliovirus Nucleic Acid Detection Kit	`697994388Nc003ZD`	Class C
4	SARS-CoV-2 Nucleic Acid Detection Kit	`697994388Nc005ZH`	Class B
5	Measles Virus Nucleic Acid Detection Kit	`697994388Nc006ZK`	Class C
6	Japanese Encephalitis Virus Nucleic Acid Detection Kit	`697994388Nc007ZM`	Class C
7	Dengue Virus Nucleic Acid Detection Kit	`697994388Nc008ZP`	Class C
8	Monkeypox Virus Nucleic Acid Detection Kit	`697994388Nc009ZR`	Class C
9	Shigella/Entamoeba histolytica Nucleic Acid Detection Kit	`697994388Nc010ZA`	Class B
10	Mycobacterium tuberculosis Nucleic Acid Detection Kit	`697994388Nc011ZC`	Class C
11	Salmonella typhi/paratyphi Nucleic Acid Detection Kit	`697994388Nc012ZE`	Class C
12	Neisseria meningitidis Nucleic Acid Detection Kit	`697994388Nc013ZG`	Class C
13	Bordetella pertussis Nucleic Acid Detection Kit	`697994388Nc014ZJ`	Class C
14	Corynebacterium diphtheriae Nucleic Acid Detection Kit	`697994388Nc015ZL`	Class C
15	Plasmodium Nucleic Acid Detection Kit	`697994388Nc016ZN`	Class C
16	Influenza A/B Virus Nucleic Acid Detection Kit	`697994388Nc017ZQ`	Class B
17	Norovirus Nucleic Acid Detection Kit	`697994388Nc018ZS`	Class B
18	Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit	`697994388Nc019ZU`	Class B
19	Vibrio parahaemolyticus Nucleic Acid Detection Kit	`697994388Nc020ZD`	Class B
20	Nipah Virus Nucleic Acid Detection Kit (Nasopharyngeal Swab)	`697994388Nc021ZF`	Class C
21	West Nile Virus Nucleic Acid Detection Kit	`697994388Nc022ZH`	Class C
22	Zika Virus Nucleic Acid Detection Kit	`697994388Nc023ZK`	Class C
23	Chikungunya Virus Nucleic Acid Detection Kit	`697994388Nc024ZM`	Class C
24	Oropouche Virus Nucleic Acid Detection Kit	`697994388Nc025ZP`	Class C
25	SARS-CoV-2 Nucleic Acid Detection Kit	`697994388Nc026ZR`	Class B
26	Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit	`697994388Nc028ZV`	Class B
27	Adenovirus (Respiratory Type) Nucleic Acid Detection Kit	`697994388Nc02922`	Class B
28	Human Metapneumovirus Nucleic Acid Detection Kit	`697994388Nc030ZG`	Class B
29	Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit	`697994388Nc031ZJ`	Class B
30	Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit	`697994388Nc032ZL`	Class B
31	Rhinovirus Nucleic Acid Detection Kit (Nasopharyngeal Swab)	`697994388Nc033ZN`	Class B
32	Bocavirus Nucleic Acid Detection Kit	`697994388Nc034ZQ`	Class B
33	Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit	`697994388Nc035ZS`	Class C
34	Mycoplasma pneumoniae Nucleic Acid Detection Kit	`697994388Nc036ZU`	Class C
35	Group A Streptococcus Nucleic Acid Detection Kit	`697994388Nc037ZW`	Class B
36	Bordetella pertussis Nucleic Acid Detection Kit (Unvaccinated)	`697994388Nc03823`	Class C
37	Streptococcus pneumoniae Nucleic Acid Detection Kit	`697994388Nc03925`	Class C
38	Haemophilus influenzae Nucleic Acid Detection Kit	`697994388Nc040ZK`	Class C
39	Legionella Nucleic Acid Detection Kit (Sputum/BALF)	`697994388Nc041ZM`	Class C
40	Klebsiella pneumoniae Nucleic Acid Detection Kit	`697994388Nc042ZP`	Class B
41	Aspergillus Nucleic Acid Detection Kit (Sputum/BALF)	`697994388Nc043ZR`	Class C
42	Cryptococcus Nucleic Acid Detection Kit (CSF)	`697994388Nc044ZT`	Class C
43	Pneumocystis jirovecii Nucleic Acid Detection Kit (BALF)	`697994388Nc045ZV`	Class C
44	Non-tuberculous Mycobacterium Nucleic Acid Detection Kit	`697994388Nc04622`	Class C
45	Dengue Virus Genotyping Nucleic Acid Detection Kit	`697994388Nc04724`	Class C

Fluorescent format — 45 devices

#	Device name	Basic UDI-DI	IVDR class
1	Vibrio cholerae Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa001W3`	Class C
2	Yellow Fever Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa002W5`	Class C
3	Poliovirus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa003W7`	Class C
4	SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa005WB`	Class B
5	Measles Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa006WD`	Class C
6	Japanese Encephalitis Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa007WF`	Class C
7	Dengue Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa008WH`	Class C
8	Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa009WK`	Class C
9	Shigella/Entamoeba histolytica Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa010W4`	Class B
10	Mycobacterium tuberculosis Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa011W6`	Class C
11	Salmonella typhi/paratyphi Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa012W8`	Class C
12	Neisseria meningitidis Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa013WA`	Class C
13	Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa014WC`	Class C
14	Corynebacterium diphtheriae Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa015WE`	Class C
15	Plasmodium Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa016WG`	Class C
16	Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa017WJ`	Class B
17	Norovirus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa018WL`	Class B
18	Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa019WN`	Class B
19	Vibrio parahaemolyticus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa020W7`	Class B
20	Nipah Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa021W9`	Class C
21	West Nile Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa022WB`	Class C
22	Zika Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa023WD`	Class C
23	Chikungunya Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa024WF`	Class C
24	Oropouche Virus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa025WH`	Class C
25	SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence Screening)	`697994388Fa026WK`	Class B
26	Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa028WP`	Class B
27	Adenovirus (Respiratory Type) Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa029WR`	Class B
28	Human Metapneumovirus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa030WA`	Class B
29	Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa031WC`	Class B
30	Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa032WE`	Class B
31	Rhinovirus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa033WG`	Class B
32	Bocavirus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa034WJ`	Class B
33	Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa035WL`	Class C
34	Mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa036WN`	Class C
35	Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa037WQ`	Class B
36	Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence, Unvaccinated)	`697994388Fa038WS`	Class C
37	Streptococcus pneumoniae Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa039WU`	Class C
38	Haemophilus influenzae Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa040WD`	Class C
39	Legionella Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)	`697994388Fa041WF`	Class C
40	Klebsiella pneumoniae Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa042WH`	Class B
41	Aspergillus Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)	`697994388Fa043WK`	Class C
42	Cryptococcus Nucleic Acid Detection Kit (Fluorescence, CSF)	`697994388Fa044WM`	Class C
43	Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)	`697994388Fa045WP`	Class C
44	Non-tuberculous Mycobacterium Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa046WR`	Class C
45	Dengue Virus Genotyping Nucleic Acid Detection Kit (Fluorescence)	`697994388Fa047WT`	Class C

Device names are reproduced verbatim from the Notified Body confirmation letter (Table 2). The fluorescent format devices carry the same target names as the non-fluorescent counterparts and are registered as separate devices with their own Basic UDI-DI.

Formats and instruments

Non-fluorescent format: isothermal amplification and CRISPR-based detection workflows.
Fluorescent format: multiplex fluorescent PCR with TaqMan-type probes, compatible with mainstream real-time PCR platforms.
Sample types, extraction requirements, time-to-result and instrument compatibility are stated per device in the Instructions for Use (IFU).

Intended use, performance and specifications

Intended use, sample types, performance characteristics and specifications are as stated in the Instructions for Use (IFU) and the applicable conformity documentation for each device. Device specifications and availability are subject to regulatory approval in each market. No absolute or comparative performance claims are made on this website.

For professional in-vitro diagnostic use only.

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