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161 device results listed.

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70845357043602

8246

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043602
Basic UDI-DI: 084535708246BE
Reference: [8246] QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043084

8235

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043084
Basic UDI-DI: 084535708235B9
Reference: [8235] QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043077

8234

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043077
Basic UDI-DI: 084535708234B7
Reference: [8234] QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041400

8205

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041400
Basic UDI-DI: 084535708205AY
Reference: [8205] QC Sets and Panels: Helix Elite™ Norovirus Control Panel (Inactivated Swab)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041202

8190

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041202
Basic UDI-DI: 084535708190BC
Reference: [8190] QC Sets and Panels: Helix Elite™ Enterovirus (EV) Control Panel (Inactivated Swab)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041158

8211

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041158
Basic UDI-DI: 084535708211AT
Reference: [8211] QC Sets and Panels: Helix Elite™ Enteric Viral Control Panel
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

70845357041141

8210

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041141
Basic UDI-DI: 084535708210AR
Reference: [8210] QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

10845357043259

HE0056N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043259
Basic UDI-DI: 08453570HE0056NZD
Reference: [HE0056N] Helix Elite™ Molecular Standards Human Papillomavirus 16 (HPV 16) Cellularity Control (Inactivated Pellet)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042184

HE0044N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042184
Basic UDI-DI: 08453570HE0044NZ2
Reference: [HE0044N] Helix Elite™ Molecular Standards Inactivated Influenza A/B and Respiratory Syncytial Virus
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042177

HE0043N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042177
Basic UDI-DI: 08453570HE0043NYX
Reference: [HE0043N] Helix Elite™ Molecular Standards Inactivated Influenza A (H3N2) Virus
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042146

HE0040N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042146
Basic UDI-DI: 08453570HE0040NYN
Reference: [HE0040N] Helix Elite™ Molecular Standards Inactivated Cytomegalovirus High Control Strain AD-169
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042115

HE0037N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042115
Basic UDI-DI: 08453570HE0037NZ6
Reference: [HE0037N] Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 2 Strain MS
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042108

HE0036N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042108
Basic UDI-DI: 08453570HE0036NZ3
Reference: [HE0036N] Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 1 Strain MacIntyre
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042078

HE0033N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042078
Basic UDI-DI: 08453570HE0033NYS
Reference: [HE0033N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 3 Strain C243
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042061

HE0032N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042061
Basic UDI-DI: 08453570HE0032NYP
Reference: [HE0032N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 2 Strain Greer
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042054

HE0031N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042054
Basic UDI-DI: 08453570HE0031NYL
Reference: [HE0031N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 1 Strain VP1
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042047

HE0030N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042047
Basic UDI-DI: 08453570HE0030NYH
Reference: [HE0030N] Helix Elite™ Molecular Standards Inactivated Influenza B Virus Strain Hong Kong/5/72
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042030

HE0029N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042030
Basic UDI-DI: 08453570HE0029NZ7
Reference: [HE0029N] Helix Elite™ Molecular Standards Inactivated Influenza A (H1N1) Virus
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042023

HE0028N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042023
Basic UDI-DI: 08453570HE0028NZ4
Reference: [HE0028N] Helix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain Long
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

10845357042016

HE0027N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042016
Basic UDI-DI: 08453570HE0027NYZ
Reference: [HE0027N] Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details