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336 device results listed.

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BioCLIA Autoimmune Reagent Kit, AMA-M2

AMA-M2, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415679
Basic UDI-DI: B-06924030415679
Reference: MY00118C
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, LC-1

LC-1, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415662
Basic UDI-DI: B-06924030415662
Reference: MY00117C
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, LKM-1

LKM-1, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415655
Basic UDI-DI: B-06924030415655
Reference: MY00116C
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, sp100

sp100, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415648
Basic UDI-DI: B-06924030415648
Reference: MY00115C
EMDN: W0102100706
EMDN description: SP 100 ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, gp210

gp210, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415631
Basic UDI-DI: B-06924030415631
Reference: MY00114C
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, GBM

GBM, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415624
Basic UDI-DI: B-06924030415624
Reference: MY00113C
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, PR3

PR3, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415617
Basic UDI-DI: B-06924030415617
Reference: MY00112C
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Nucleosome

Nucleosome, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSterile

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415594
Basic UDI-DI: B-06924030415594
Reference: MY00110C
EMDN: W0102100117
EMDN description: NUCLEOSOME ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, MPO

MPO, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415600
Basic UDI-DI: B-06924030415600
Reference: MY00111C
EMDN: W0102100402
EMDN description: MPO ANCA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Histone

Histone, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415570
Basic UDI-DI: B-06924030415570
Reference: MY00108C
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, CENP-B

CENP-B, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415587
Basic UDI-DI: B-06924030415587
Reference: MY00109C
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 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, PM-Scl

PM-Scl, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415563
Basic UDI-DI: B-06924030415563
Reference: MY00107C
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 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, PCNA

PCNA, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415556
Basic UDI-DI: B-06924030415556
Reference: MY00106C
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ribosomal P

Ribosomal P, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415549
Basic UDI-DI: B-06924030415549
Reference: MY00105C
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ro52

Ro52, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415532
Basic UDI-DI: B-06924030415532
Reference: MY00104C
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 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Scl-70

Scl-70, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415525
Basic UDI-DI: B-06924030415525
Reference: MY00103C
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Jo-1

Jo-1, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415518
Basic UDI-DI: B-06924030415518
Reference: MY00102C
EMDN: W0102100108
EMDN description: JO-1
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Sm

Sm, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415501
Basic UDI-DI: B-06924030415501
Reference: MY00101C
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, nRNP/Sm

nRNP/Sm, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415495
Basic UDI-DI: B-06924030415495
Reference: MY00100C
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, SS-B/La

SS-B/La, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415488
Basic UDI-DI: B-06924030415488
Reference: MY00099C
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details