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BioCLIA Autoimmune Reagent Kit, nRNP/Sm

nRNP/Sm, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402662
Basic UDI-DI: B-06924030402662
Reference: MY00151
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, SS-B/La

SS-B/La, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402655
Basic UDI-DI: B-06924030402655
Reference: MY00150
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ro60

Ro60, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402648
Basic UDI-DI: B-06924030402648
Reference: MY00149
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, dsDNA

dsDNA,100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402631
Basic UDI-DI: B-06924030402631
Reference: MY00148
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Autoantibodies in Autoimmune Liver Diseases

Liver-4, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030401009
Basic UDI-DI: B-06924030401009
Reference: MB00180
EMDN: W0102100701
EMDN description: HEPATITIS AUTOANTIBODY SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Autoantibodies in Autoimmune Liver Diseases

Liver-8, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400996
Basic UDI-DI: B-06924030400996
Reference: MB00179
EMDN: W0102100701
EMDN description: HEPATITIS AUTOANTIBODY SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis

Vasculitis-2, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400989
Basic UDI-DI: B-06924030400989
Reference: MB00178
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis

Vasculitis-3, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400972
Basic UDI-DI: B-06924030400972
Reference: MB00177
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ENA-7, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400965
Basic UDI-DI: B-06924030400965
Reference: MB00176
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ANA-9, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400958
Basic UDI-DI: B-06924030400958
Reference: MB00175
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ANA-13, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400941
Basic UDI-DI: B-06924030400941
Reference: MB00174
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ANA-15, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400934
Basic UDI-DI: B-06924030400934
Reference: MB00173
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BIOHIT Celiac quick test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020808
Basic UDI-DI: B-06419587020808
Reference: 602080
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

BIOHIT Celiac quick test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020709
Basic UDI-DI: B-06419587020709
Reference: 602070
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Biocard™ Celiac Home

3-028-200

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842928015
Basic UDI-DI: B-06416842928015
Reference: 3-028-200
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:48

Manufacturer products View details

Blocard ™ Celiac Test

Biocard Celiac Test

IVD generalIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842828018
Basic UDI-DI: B-06416842828018
Reference: 3-028-000
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

AURYX 90 Anti-TPO Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600403
Basic UDI-DI: B-05907514600403
Reference: I20-R0026
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:51

Manufacturer products View details

AURYX 90 Anti-TPO Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600397
Basic UDI-DI: B-05907514600397
Reference: I20-R0025
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:51

Manufacturer products View details

AURYX 90 Anti-TG Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600380
Basic UDI-DI: B-05907514600380
Reference: I20-R0024
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:51

Manufacturer products View details

AURYX 90 Anti-TG Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600373
Basic UDI-DI: B-05907514600373
Reference: I20-R0023
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:51

Manufacturer products View details