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143 device results listed.

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Optitrol NAT HIV Screening, 5x 1,2 mL

NT01031

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956166
Basic UDI-DI: 0816784020095YE
Reference: NT01031
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HIV Viral Load, 5x 1.2 mL

NT01033

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956180
Basic UDI-DI: 0816784020113XP
Reference: NT01033
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HCV Viral Load, 5x 1.2 mL

NT01023

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956128
Basic UDI-DI: 0816784020112XM
Reference: NT01023
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HCV Screening, 5x 1,2 mL

NT01021

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956104
Basic UDI-DI: 0816784020096YG
Reference: NT01021
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HBV Viral Load, 5x 1.2 mL

NT01013

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956081
Basic UDI-DI: 0816784020111XK
Reference: NT01013
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HBV Screening, 5x 1,2 mL

NT01011

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956067
Basic UDI-DI: 0816784020094YC
Reference: NT01011
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID Multi-Marker Negative Control 2 x 4mL

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substances

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090917
Basic UDI-DI: 0816784020080XZ
Reference: 2010-0260
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID HAV IgM Positive Control

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090900
Basic UDI-DI: 0816784020081Y3
Reference: 2015-0337
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN Babesia Molecular Controls Kit

2020-0155

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090047
Basic UDI-DI: 0816784020062XX
Reference: 2020-0155
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HBV Viral Load, 10x 1.2 mL

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956098
Basic UDI-DI: 0816784020111XK
Reference: NT01014
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 15.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HCV Viral Load, 10x 1.2 mL

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956135
Basic UDI-DI: 0816784020112XM
Reference: NT01024
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 15.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN Anti-SARS-CoV-2 IgM Controls Kit

2015-0232

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00860006589721
Basic UDI-DI: B-00860006589721
Reference: 2015-0232
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:45

Manufacturer products Authorised representative products Authorised representative actors View details

A21 Series 1000 CE

2000-0028

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00860006589707
Basic UDI-DI: B-00860006589707
Reference: 2000-0028
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:45

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID ToRC IgM Positive Control

2000-0102

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090030
Basic UDI-DI: B-00850041090030
Reference: 2000-0102
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID Rubella IgM Positive Control

2015-0240

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090023
Basic UDI-DI: B-00850041090023
Reference: 2015-0240
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID ToRCH IgG Negative Control

2010-0023

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090016
Basic UDI-DI: B-00850041090016
Reference: 2010-0023
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID ToRCH IgG Positive Control

2000-0101

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090009
Basic UDI-DI: B-00850041090009
Reference: 2000-0101
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

A1 Negative Control

2010-0013

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784021007
Basic UDI-DI: B-00816784021007
Reference: 2010-0013
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN Anti-SARS-CoV-2 Series 2000

2015-0225

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020970
Basic UDI-DI: B-00816784020970
Reference: 2015-0225
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN Anti-SARS-CoV-2 Series 1000

2015-0222

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020963
Basic UDI-DI: B-00816784020963
Reference: 2015-0222
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details