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329 device results listed.

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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

IDS ANCA/GBM Control Set

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694064
Basic UDI-DI: B-05060169694064
Reference: IS-AI1730
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

Autoimmune Maker Control I

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359520560
Basic UDI-DI: 697015090000127H9
Reference: ZKE010101
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

Histones IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738909
Basic UDI-DI: 692591270353HM
Reference: CC359
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

ANA Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738831
Basic UDI-DI: 692591270132H3
Reference: CC830
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

dsDNA IgG Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738824
Basic UDI-DI: 692591270122GY
Reference: CC831
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

SMA IgG Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738688
Basic UDI-DI: 692591270331HB
Reference: CC367
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

Autoimmune Diabetes Multi Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738626
Basic UDI-DI: 692591270126H8
Reference: CC829
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

DGP IgA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738336
Basic UDI-DI: 692591270324HE
Reference: CC405
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

DGP IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738329
Basic UDI-DI: 692591270323HC
Reference: CC404
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

tTG IgG Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738305
Basic UDI-DI: 692591270321H8
Reference: CC402
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details