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811 device results listed.

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BioCLIA Autoimmune Calibrator Set, CTD Screen

CTD Screen, 2 X 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030405298
Basic UDI-DI: B-06924030405298
Reference: MY00970
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, CTD Screen

CTD Screen, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030405281
Basic UDI-DI: B-06924030405281
Reference: MY00969
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, ENA Screen I

ENA Screen I, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404666
Basic UDI-DI: B-06924030404666
Reference: MY00351
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Nucleosome

Nucleosome, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404291
Basic UDI-DI: B-06924030404291
Reference: MY00314
EMDN: W0102100117
EMDN description: NUCLEOSOME ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, CENP-B

CENP-B, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404284
Basic UDI-DI: B-06924030404284
Reference: MY00313
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Histone

Histone, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404277
Basic UDI-DI: B-06924030404277
Reference: MY00312
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, PM-Scl

PM-Scl, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404260
Basic UDI-DI: B-06924030404260
Reference: MY00311
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, PCNA

PCNA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404253
Basic UDI-DI: B-06924030404253
Reference: MY00310
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Ribosomal P

Ribosomal P, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404246
Basic UDI-DI: B-06924030404246
Reference: MY00309
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Ro52

Ro52, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404239
Basic UDI-DI: B-06924030404239
Reference: MY00308
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Scl-70

Scl-70, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404222
Basic UDI-DI: B-06924030404222
Reference: MY00307
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Jo-1

Jo-1, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404215
Basic UDI-DI: B-06924030404215
Reference: MY00306
EMDN: W0102100108
EMDN description: JO-1
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Sm

Sm, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404208
Basic UDI-DI: B-06924030404208
Reference: MY00305
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, nRNP/Sm

nRNP/Sm, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404192
Basic UDI-DI: B-06924030404192
Reference: MY00304
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, SS-B/La

SS-B/La, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404185
Basic UDI-DI: B-06924030404185
Reference: MY00303
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Ro60

Ro60, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404178
Basic UDI-DI: B-06924030404178
Reference: MY00302
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, dsDNA

dsDNA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404161
Basic UDI-DI: B-06924030404161
Reference: MY00301
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, ENA Screen I

ENA Screen I, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403645
Basic UDI-DI: B-06924030403645
Reference: MY00249
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, Nucleosome

Nucleosome, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403270
Basic UDI-DI: B-06924030403270
Reference: MY00212
EMDN: W0102100117
EMDN description: NUCLEOSOME ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, CENP-B

CENP-B, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403263
Basic UDI-DI: B-06924030403263
Reference: MY00211
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 09:00

Manufacturer products Authorised representative products Authorised representative actors View details