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646 device results listed.

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Anti-TPO CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541961
Basic UDI-DI: 697015090000023GU
Reference: CME0703
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541862
Basic UDI-DI: 697015090000022GS
Reference: CME0603
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

rT3 CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541817
Basic UDI-DI: 697015090000264HL
Reference: CME1103
EMDN: W01020404
EMDN description: REVERSE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

TRAb CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541763
Basic UDI-DI: 697015090000118H8
Reference: CME1003
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

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FT4 CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541664
Basic UDI-DI: 697015090000005GS
Reference: CME0503
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

FT3 CLIA Microparticles

AutoLumo Analyzers

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541565
Basic UDI-DI: 697015090000004GQ
Reference: CME0403
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

T3 CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541466
Basic UDI-DI: 697015090000001GJ
Reference: CME0103
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
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

TSH CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541367
Basic UDI-DI: 697015090000003GN
Reference: CME0303
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

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T4 CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359541268
Basic UDI-DI: 697015090000002GL
Reference: CME0203
EMDN: W01020407
EMDN description: THYROXINE
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

AST-ST01

Automated Microbiology System Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359535403
Basic UDI-DI: 697015090000195HS
Reference: ME1201
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
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

AST-GP01

Automated Microbiology System Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359535373
Basic UDI-DI: 697015090000194HQ
Reference: ME1101
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
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

Sputum Processing Reagent

AutoStreak S1800

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359531634
Basic UDI-DI: 697015090000170HA
Reference: AS030101
EMDN: W0104010899
EMDN description: BUFFERS, STAINS - OTHER
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

Anaerobic culture bottle SN

Automated Blood Culture system, Microbial Detection System, Automated Microbial Detection System

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525800
Basic UDI-DI: 697015090000149HK
Reference: MC0309
EMDN: W0104010501
EMDN description: BOTTLES FOR MANUAL BLOOD CULTURE
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

Aerobic Culture Bottle SP

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525794
Basic UDI-DI: 697015090000148HH
Reference: MC0308
EMDN: W0104010501
EMDN description: BOTTLES FOR MANUAL BLOOD CULTURE
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

AST-NF01

Automated Microbiology System Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359521857
Basic UDI-DI: 697015090000193HN
Reference: ME1001
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
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

AST-EB01

Automated Microbiology System Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359521826
Basic UDI-DI: 697015090000192HL
Reference: ME0901
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
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

Aerobic culture bottle SA

Automated Blood Culture system， Microbial Detection System，Automated Microbial Detection System

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525787
Basic UDI-DI: 697015090000138HE
Reference: MC0307
EMDN: W0104010501
EMDN description: BOTTLES FOR MANUAL BLOOD CULTURE
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

Thyroid Speciality Control

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359522656
Basic UDI-DI: 697015090000130GW
Reference: ZK0501L106
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
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

AutoLumo S100 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: 06942359521680
Basic UDI-DI: 697015090000133H4
Reference: CA062301
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
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

AutoLumo HER-2/neu CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359521642
Basic UDI-DI: 697015090000132H2
Reference: CA062201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details