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Emit II Plus Specialty Drug Control Positive

IVDR_67_GLA_DUB-C_B_REAG_Specialty Drug Controls Neg and Pos

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601090
Basic UDI-DI: 0405686901191VC
Reference: 10718701
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

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

Thrombosis Marker Multi Control

Low: 2×2.0 mL High: 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-DCC0234Z
Basic UDI-DI: B-DCC0234Z
Reference: DCC023
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Calcitonin Control

Low: 1×1.0 mL High: 1×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0214V
Basic UDI-DI: B-DCC0214V
Reference: DCC021
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
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

Multiparametric controls H

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168007351
Basic UDI-DI: B-05415168007351
Reference: MPCOX-005
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details

Multiparametric controls M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168007344
Basic UDI-DI: B-05415168007344
Reference: MPCON-005
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details

IDS ANA Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693883
Basic UDI-DI: B-05060169693883
Reference: IS-AI1130
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 05.08.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS Direct Renin Control Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690394
Basic UDI-DI: B-05060169690394
Reference: IS-3430
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 05.08.2026 13:44

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

CRP Control High

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816796
Basic UDI-DI: 6438153BU00105BG
Reference: 981679
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

Manufacturer products View details

Rheumatoid Factors Control

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153812521
Basic UDI-DI: 6438153BU00165C2
Reference: 981252
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 21:59

Manufacturer products View details

CRP Control

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153812514
Basic UDI-DI: 6438153BU00104BE
Reference: 981251
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 21:59

Manufacturer products View details