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319 device results listed.

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AESQC® IFA Negative Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510783
Basic UDI-DI: B-04250289510783
Reference: AESQCIFANEG
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:13

Manufacturer products View details

Aptiva® APS IgA Controls

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040846
Basic UDI-DI: 843079304084648
Reference: 725122
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.08.2026 16:41

Manufacturer products Authorised representative products Authorised representative actors View details

APS Multi Control

Level 1:2x2.0 mL Level 2:2x2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC02555
Basic UDI-DI: B-DCC02555
Reference: DCC025
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 15:27

Manufacturer products Authorised representative products Authorised representative actors View details

ENA Control

Negative: 2×2.0 mL Positive: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0224X
Basic UDI-DI: B-DCC0224X
Reference: DCC022
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 15:27

Manufacturer products Authorised representative products Authorised representative actors View details

AESQC® ANA HEp-2 Nucleolar

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510943
Basic UDI-DI: B-04250289510943
Reference: AESQCANA09
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

AESQC® ANA HEp-2 Panel 1

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510844
Basic UDI-DI: B-04250289510844
Reference: AESQCIFANAP1
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

AESQC® ANA HEp-2 Cytoplasmic

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510837
Basic UDI-DI: B-04250289510837
Reference: AESQCANA21
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

AESQC® ANA HEp-2 Speckled

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510813
Basic UDI-DI: B-04250289510813
Reference: AESQCANA04
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

AESQC® ANA HEp-2 Centromere

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510806
Basic UDI-DI: B-04250289510806
Reference: AESQCANA03
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

AESQC® ANA HEp-2 Homogeneous

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510790
Basic UDI-DI: B-04250289510790
Reference: AESQCANA01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

Anti-TSHR Control

Low: 2×2.0 mL High: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0195A
Basic UDI-DI: B-DCC0195A
Reference: DCC019
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Autoimmune Diabetes Multi Control

Negative: 2×2.0 mL Positive: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0114S
Basic UDI-DI: B-DCC0114S
Reference: DCC011
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Celiac Disease Multi Control

Negative: 2×2.0 mL Positive: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0104Q
Basic UDI-DI: B-DCC0104Q
Reference: DCC010
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

ANA Control

Negative: 2×1.0 mL Positive: 2×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC00855
Basic UDI-DI: B-DCC00855
Reference: DCC008
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

dsDNA IgG Control

Negative: 2×1.0 mL Positive: 2×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC00753
Basic UDI-DI: B-DCC00753
Reference: DCC007
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva

Aptiva® Celiac IgA Disease Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040587
Basic UDI-DI: B-08430793040587
Reference: 724122
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva

Aptiva® Celiac Disease IgG Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040525
Basic UDI-DI: B-08430793040525
Reference: 724102
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva

Aptiva® CTD Essential Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040198
Basic UDI-DI: B-08430793040198
Reference: 723102
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

IDS APS IgG Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694187
Basic UDI-DI: B-05060169694187
Reference: IS-AI1530
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Thyroid Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694095
Basic UDI-DI: B-05060169694095
Reference: IS-AI1930
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details