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Rubella IgM 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: 06942359551946
Basic UDI-DI: 697015090000101GP
Reference: CMK0303
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella IgG 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: 06942359551892
Basic UDI-DI: 697015090000106GZ
Reference: CMK0803
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella Virus IgM (CLIA)

105-012512-00, 105-012513-00, 105-012515-00, 105-012516-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021043
Basic UDI-DI: 69449040004W-RVIgM*****DU
Reference: 105-012513-00
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella Virus IgG (CLIA)

105-012518-00, 105-012519-00, 105-012521-00, 105-012522-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053020909
Basic UDI-DI: 69449040004W-RVIgG*****BE
Reference: 105-012522-00
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Rubella IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715689
Basic UDI-DI: 692591270106H2
Reference: C88036M-L
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Rubella IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715672
Basic UDI-DI: 692591270105GY
Reference: C88035G-L
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® RUB IgG II

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064556
Basic UDI-DI: 357302BUDI000077TD
Reference: 30221
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

Rubella IgM Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRM-302VE
Basic UDI-DI: B-IRM-302VE
Reference: IRM-302
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Rubella IgG II

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

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771102940
Basic UDI-DI: 80567713172605B
Reference: LIAISON® Rubella IgG II
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details

LIAISON® Rubella IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100847
Basic UDI-DI: 80567713107304A
Reference: 310730
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details

VIDAS® RUB IgM

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064488
Basic UDI-DI: 357302BUDI000076TB
Reference: 30214
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:49

Manufacturer products View details

IMMULITE 2000 Rubella Quantitative IgG

IVDR_67_LLB_DUB-C_C_REAG_KIT_Rubella Quantitative IgG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962054
Basic UDI-DI: 0405686901462VL
Reference: 10381338
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

08054320950141

IDS Rubella IgG Avidity

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

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950141
Basic UDI-DI: 805432095ISID5301M5
Reference: IS-ID5301
EMDN: W0105040199
EMDN description: RUBELLA VIRUS REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950059

IDS Rubella IgM

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

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950059
Basic UDI-DI: 805432095ISID5202M2
Reference: IS-ID5202
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950042

IDS Rubella IgG

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

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950042
Basic UDI-DI: 805432095ISID5201LY
Reference: IS-ID5201
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

+ENTIRUBM0400DS02

NovaLisa® Rubella Virus IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRUBM0400DS02
Basic UDI-DI: B-+ENTIRUBM0400DS02
Reference: RUBM0400DS
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRUBM040004

NovaLisa® Rubella Virus IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRUBM040004
Basic UDI-DI: B-+ENTIRUBM040004
Reference: RUBM0400
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRUBG04000+

NovaLisa® Rubella Virus IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRUBG04000+
Basic UDI-DI: B-+ENTIRUBG04000+
Reference: RUBG0400
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE570910G

Rubella Virus IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE570910G
Basic UDI-DI: B-+ENTIRE570910G
Reference: RE57091
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

Manufacturer products View details

+ENTIRE570810F

Rubella Virus IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE570810F
Basic UDI-DI: B-+ENTIRE570810F
Reference: RE57081
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

Manufacturer products View details