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Positive control (IgA, human), 50x concentrated

CL 2525 A

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016155263
Basic UDI-DI: B-04049016155263
Reference: CL 2525-0507 A
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 23:55

Manufacturer products View details

SeroQal MALARIA 101

SeroQal

IVD generalIVDDNo longer on the marketHuman tissuesProfessional testingReagent

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03770024891003
Basic UDI-DI: B-03770024891003
Reference: 229592
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 23:41

Manufacturer products View details

Helix Elite™ Molecular Standards: Inactivated Standard

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043266
Basic UDI-DI: 08453570HE0057NZG
Reference: [HE0057N] Helix Elite™ Molecular Standards Human Papillomavirus 18 (HPV 18) 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: 21.09.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

Helix Elite™ Molecular Standards: Inactivated Standard

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042139
Basic UDI-DI: 08453570HE0039NZC
Reference: [HE0039N] Helix Elite™ Molecular Standards Inactivated Cytomegalovirus Low 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: 21.09.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

Helix Elite™ Molecular Standards: Inactivated Standard

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042122
Basic UDI-DI: 08453570HE0038NZ9
Reference: [HE0038N] Helix Elite™ Molecular Standards Inactivated Varicella Zoster Virus Strain VZ-10
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 21.09.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

AMPLIRUN® PARAINFLUENZA 3 RNA CONTROL

MBC039

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040321898
Basic UDI-DI: 843604032MBC0390139
Reference: MBC039
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 21.09.2026 22:26

Manufacturer products View details

Boditech IGRA-TB Control

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133049013
Basic UDI-DI: 880613306089DP
Reference: CFPO-294
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Control SARS-CoV-2 Ag

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103763
Basic UDI-DI: 80567713114914N
Reference: 311491
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 21:38

Manufacturer products View details

Syphilis Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-SCSYP-D-LWR
Basic UDI-DI: B-SCSYP-D-LWR
Reference: Syphilis Control
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID-Chagas

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523442541
Basic UDI-DI: 539152344SERO11DY
Reference: 10035935190
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: -
Last updated: 11.08.2026 23:51

Manufacturer products View details

IPC

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

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730169
Basic UDI-DI: 912012773IPCEV
Reference: 09120127730169
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Austria
Authorised representative: -
Last updated: 10.08.2026 16:22

Manufacturer products View details

VZV - ELITe Positive Control

VZV ELITe MGB® Kit