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GeneProof Universal Internal Control

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696305079
Basic UDI-DI: 859569630004Q9
Reference: UNIC/GP/050
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 17:04

Manufacturer products View details

VIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL

VEC001

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290142
Basic UDI-DI: 843661029VEC00101GM
Reference: VEC001
EMDN: W0105080806
EMDN description: MYCOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:57

Manufacturer products View details

CONTROL POSITIVO EN SECO GDH-TOXINS / DRY GDH-TOXINS POSITIVE CONTROL

9.065.XXX.12.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004808
Basic UDI-DI: 8429577906512DH
Reference: 9.065.011.12.000
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:18

Manufacturer products View details

CONTROL POSITIVO EN SECO H.PYL-TF || H.PYL-TF DRY POSITIVE CONTROL

9.231.XXX.12.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004051
Basic UDI-DI: 8429577923112CW
Reference: 9.231.011.12.000
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control

9.144.011.12.000

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003948
Basic UDI-DI: 8429577914412D9
Reference: 9.144.011.12.000
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

CONTROL POSITIVO EN SECO ROTA-ADENO-NORO || DRY POSITIVE CONTROL ROTA-ADENO-NORO

9.050.XXX.12.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003481
Basic UDI-DI: 8429577905012CH
Reference: 9.050.011.12.000
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

REDx STI Negative

RED-99-M1

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesSingle use

Manufacturer: Microbix Biosystems Inc.
Manufacturer SRN: CA-MF-000028149
UDI-DI: 07540224000200
Basic UDI-DI: 7540224504119A
Reference: RED-99-M1
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

REDx Mycoplasma genitalium Positive Control

RED-63-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesSingle useSterile

Manufacturer: Microbix Biosystems Inc.
Manufacturer SRN: CA-MF-000028149
UDI-DI: 07540224000149
Basic UDI-DI: 754022447323AJ
Reference: RED-63-01
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

REDxFLOQ Respiratory Swab Negative Control

RED-S-99-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesSingle use

Manufacturer: Microbix Biosystems Inc.
Manufacturer SRN: CA-MF-000028149
UDI-DI: 07540224000309
Basic UDI-DI: 754022464922BF
Reference: RED-S-99-01
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

REDx SARS-CoV-2 Positive Control

RED-19-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesSingle use

Manufacturer: Microbix Biosystems Inc.
Manufacturer SRN: CA-MF-000028149
UDI-DI: 07540224000217
Basic UDI-DI: 754022464748BP
Reference: RED-19-01
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

REDx HPV 16 Positive Control

RED-62-16

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesSingle use

Manufacturer: Microbix Biosystems Inc.
Manufacturer SRN: CA-MF-000028149
UDI-DI: 07540224000019
Basic UDI-DI: 754022452766AY
Reference: RED-62-16
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

GeneProof Universal Internal Control

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696305086
Basic UDI-DI: 859569630004Q9
Reference: UNIC/GP/010
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

TaqPath™ Menu | GeneProof™ Universal Internal Control

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696305093
Basic UDI-DI: 859569630004Q9
Reference: A58250
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

06973315734875

Quality Control Kit for Logilet Respiratory Pathogen Panel

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734875
Basic UDI-DI: 6973315734875B3
Reference: QC1011
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-Dengue Virus IgM (CLIA) Controls

Anti-Dengue Virus IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145565343
Basic UDI-DI: 69471455403VZ
Reference: 160201403MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-Dengue Virus IgG (CLIA) Controls

Anti-Dengue Virus IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145565336
Basic UDI-DI: 69471455402VX
Reference: 160201402MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI CMV IgG (CLIA) Controls

CMV IgG (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145561765
Basic UDI-DI: 69471455477WW
Reference: 160201477MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Toxo IgG (CLIA) Controls

Toxo IgG (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145561727
Basic UDI-DI: 69471455476WU
Reference: 160201476MT
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Respiratory Syncytial Virus IgM (CLIA) Controls

Respiratory Syncytial Virus IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547622
Basic UDI-DI: 69471455277WL
Reference: 160201277MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Legionella pneumophila IgM (CLIA) Controls

Legionella pneumophila IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547547
Basic UDI-DI: 69471455276WJ
Reference: 160201276MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details