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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

Atellica IM Rubella IgM Quality Control (Rub M QC)

IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599847
Basic UDI-DI: 0405686901867WJ
Reference: 10995669
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Toxo M Quality Control Material

IVDR_67_TTN_DUB-C_C_REAG_Toxo M QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414208763
Basic UDI-DI: 0405686901871W9
Reference: 10310326
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Rub G quality control material

IVDR_67_TTN_DUB-C_C_REAG_Rub G QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414201429
Basic UDI-DI: 0405686902037V8
Reference: 10310284
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Toxoplasma IgG Control Module

IVDR_67_LLB_DUB-C_C_REAG_Toxoplasma IgG Control Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414976747
Basic UDI-DI: 0405686901492VV
Reference: 10469600
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Rubella IgG Controls

IVDR_67_LLB_DUB-C_C_REAG_Rubella IgG Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414976730
Basic UDI-DI: 0405686901486W2
Reference: 10469599
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Rubella IgM Control Module

IVDR_67_LLB_DUB-C_C_REAG_Rubella IgM Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414976716
Basic UDI-DI: 0405686901487W4
Reference: 10469597
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Quantitative HBsAg Quality Control (QHBs QC)

IVDR_67_LLB_DUB-C_C_REAG_QHBs QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414246970
Basic UDI-DI: 0405686901507VH
Reference: 11200644
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Hepatitis A Total Quality Control (aHAVT QC)

IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597782
Basic UDI-DI: 0405686900759W7
Reference: 10995448
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Hepatitis A IgM Quality Control (aHAVM QC)

IVDR_67_TTN_DUB-C_B_REAG_aHAVM_QC

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597744
Basic UDI-DI: 0405686900758W5
Reference: 10995445
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Toxo G Quality Control Material

IVDR_67_TTN_DUB-C_C_REAG_ToxoG_QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414208756
Basic UDI-DI: 0405686900835VW
Reference: 10310325
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

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

D-IM4292323L2

anti-TP Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4292323L2
Basic UDI-DI: B-IM4292323L2
Reference: IM4292323
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4291323KT

anti-TP Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4291323KT
Basic UDI-DI: B-IM4291323KT
Reference: IM4291323
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

AdvanSure™ i3 TB-IGRA Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Invitros Co., Ltd
Manufacturer SRN: KR-MF-000023980
UDI-DI: D-IFC0002K00AR
Basic UDI-DI: B-IFC0002K00AR
Reference: IFC0002K00
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Antigen Control Kit

GCSTR-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-PN2Q4
Basic UDI-DI: B-GCSTR-PN2Q4
Reference: GCSTR-PN2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Antigen Control Kit

GCSTR-PN2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-PN2HGTH
Basic UDI-DI: B-GCSTR-PN2HGTH
Reference: GCSTR-PN2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details