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301 device results listed.

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NOVA Lite® IFA Hu (ANNA-1) Positive Control

NOVA Lite® IFA Hu (ANNA-1) Positive Control

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001021
Basic UDI-DI: 8426950594284A4
Reference: 704073
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details

Evo Autoimmune Control, b2-GPI IgG/IgM

Evo Autoimmune Control, b2-GPI IgG/IgM

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155172
Basic UDI-DI: 8058945153AU2020/12MC
Reference: 3AU2020/12
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

Evo Autoimmune Control, AMA IgG

Evo Autoimmune Control, AMA IgG

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155158
Basic UDI-DI: 8058945153AU2020/11MA
Reference: 3AU2020/11
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

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Evo Autoimmune Control, AGA/tTG IgA/IgG

Evo Autoimmune Control, AGA/tTG IgA/IgG

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155127
Basic UDI-DI: 8058945153AU2020/7EK
Reference: 3AU2020/7
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

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Evo Autoimmune Control, MPO/PR3/GBM IgG

Evo Autoimmune Control, MPO/PR3/GBM IgG

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155103
Basic UDI-DI: 8058945153AU2020/6EH
Reference: 3AU2020/6
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

Evo Autoimmune Control, Tg/TPO IgG

Evo Autoimmune Control, Tg/TPO IgG

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155080
Basic UDI-DI: 8058945153AU2020/4ED
Reference: 3AU2020/4
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

Evo Autoimmune Control, CL IgG/IgM

Evo Autoimmune Control, CL IgG/IgM

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155059
Basic UDI-DI: 8058945153AU2020/3EB
Reference: 3AU2020/3
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

Evo Autoimmune Control, DNA/HIS/NUC IgG

Evo Autoimmune Control, DNA/HIS/NUC IgG

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155035
Basic UDI-DI: 8058945153AU2020/2E9
Reference: 3AU2020/2
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

Evo Autoimmune Control, ANA/ENA IgG

Evo Autoimmune Control, ANA/ENA IgG

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945154991
Basic UDI-DI: 8058945153AU2020/1E7
Reference: 3AU2020/1
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

MosaiQ® AiPlex VAS Quality Controls

MosaiQ® AiPlex VAS Quality Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: AliveDx Suisse SA
Manufacturer SRN: CH-MF-000024025
UDI-DI: 07640327462216
Basic UDI-DI: 764032746AIPLEXVASQC7Q
Reference: 132020
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MosaiQ® AiPlex CTDplus Quality Controls XL

MosaiQ® AiPlex CTDplus Quality Controls XL

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: AliveDx Suisse SA
Manufacturer SRN: CH-MF-000024025
UDI-DI: 07640327462094
Basic UDI-DI: 764032746AIPLEXCTDPLUQCP8
Reference: 132003
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MosaiQ® AiPlex CD Quality Controls

MosaiQ® AiPlex CD Quality Controls

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

Manufacturer: AliveDx Suisse SA
Manufacturer SRN: CH-MF-000024025
UDI-DI: 07640327462063
Basic UDI-DI: 764032746AIPLEXCDQCSZ5
Reference: 132010
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MosaiQ® AiPlex CTD Quality controls

MosaiQ® AiPlex CTD Quality controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: AliveDx Suisse SA
Manufacturer SRN: CH-MF-000024025
UDI-DI: 07640327462025
Basic UDI-DI: 764032746AIPLEXQCZU
Reference: 132001
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

EliA AIH Positive Control 200

EliA Control

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066020518
Basic UDI-DI: 7333066BUDI0048MA
Reference: 83-1172-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

EliA DFS70 Positive Control 200

EliA DFS70

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066020105
Basic UDI-DI: 7333066BUDI0129MB
Reference: 83-1169-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

EliA M2 Positive Control 2500/5000

EliA M2

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013527
Basic UDI-DI: 7333066BUDI0122LV
Reference: 83-1105-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA Calprotectin Negative Control 250

EliA Calprotectin 2

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013367
Basic UDI-DI: 7333066BUDI0116M2
Reference: 83-1085-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA APS Positive Control 2500/5000

EliA Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013183
Basic UDI-DI: 7333066BUDI0020LL
Reference: 83-1078-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA CCP Positive Control 250

EliA CCP

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013015
Basic UDI-DI: 7333066BUDI0081M8
Reference: 83-1035-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA ANA Positive Control 250

EliA Control

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066012995
Basic UDI-DI: 7333066BUDI0047M8
Reference: 83-1033-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details