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Immunochemistry Systems CAL 1 Calibrator 1

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590200060
Basic UDI-DI: 150995901449560LW
Reference: 449560
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech iFOB Neo Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048979
Basic UDI-DI: 880613307142D9
Reference: CFPO-379
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-CL IgA Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178770
Basic UDI-DI: 697015090000330H8
Reference: CA013403
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-CL IgM Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178763
Basic UDI-DI: 697015090000329HP
Reference: CA013303
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-CL IgG Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178756
Basic UDI-DI: 697015090000328HM
Reference: CA013203
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-CL Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178749
Basic UDI-DI: 697015090000327HK
Reference: CA013103
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-β2-GP1 IgM Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178718
Basic UDI-DI: 697015090000324HD
Reference: CA012803
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-β2-GP1 IgG Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178701
Basic UDI-DI: 697015090000323HB
Reference: CA012703
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-β2-GP1 IgA Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178695
Basic UDI-DI: 697015090000322H9
Reference: CA012603
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Anti-β2-GP1 Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178688
Basic UDI-DI: 697015090000321H7
Reference: CA012503
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo H-FABP Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178138
Basic UDI-DI: 697015090000259HT
Reference: CA140601
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo HS-cTnT Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177865
Basic UDI-DI: 697015090000260HC
Reference: CA100701
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo PIVKA-II CLIA Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177759
Basic UDI-DI: 697015090000083HE
Reference: CA061001
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo CA19-9 Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177742
Basic UDI-DI: 697015090000010GK
Reference: CA060401
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo CA242 Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177735
Basic UDI-DI: 697015090000016GX
Reference: CA060301
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo SCCA Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177704
Basic UDI-DI: 697015090000014GT
Reference: CA060801
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Insulin Calibrators

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177544
Basic UDI-DI: 697015090000072H9
Reference: CA090101
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo C-Peptide Calibrators

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177537
Basic UDI-DI: 697015090000073HB
Reference: CA090201
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo PCT Calibrators

AutoLumo Analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177513
Basic UDI-DI: 697015090000043H2
Reference: CA100601
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Calcitonin Calibrators

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177421
Basic UDI-DI: 697015090000048HC
Reference: CA110201
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details