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Last updated

22.09.2026 11:56

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Active filter:EMDN:W01021006

193 device results listed.

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04260154636401

Anti-human tissue transglutaminase sIgA / IgA ELISA (96 tests)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
Manufacturer
ImmuChrom GmbH
Manufacturer SRN
DE-MF-000033427
UDI-DI
04260154636401
Basic UDI-DI
B-04260154636401
Reference
IC6400
EMDN
W0102100601
EMDN description
TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 11:37
Manufacturer productsView details
04260154636319

Anti-gliadin sIgA / IgA in stool ELISA (960 tests)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
Manufacturer
ImmuChrom GmbH
Manufacturer SRN
DE-MF-000033427
UDI-DI
04260154636319
Basic UDI-DI
B-04260154636319
Reference
IC6310
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 11:37
Manufacturer productsView details
04260154636302

Anti-gliadin sIgA / IgA ELISA (96 tests)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
Manufacturer
ImmuChrom GmbH
Manufacturer SRN
DE-MF-000033427
UDI-DI
04260154636302
Basic UDI-DI
B-04260154636302
Reference
IC6300
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 11:37
Manufacturer productsView details
07640164860015

CELIAC DISEASE SCREENING TEST

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use
Manufacturer
PRIMA Lab SA
Manufacturer SRN
CH-MF-000034473
UDI-DI
07640164860015
Basic UDI-DI
764016486CE2H867
Reference
CE2H88000KIT01IT
EMDN
W0102100602
EMDN description
TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country
Italy
Safety summary (SSCP/SSP)
New Celiac Test · Rev. 2025-01
Authorised representative
QbD RepS BV
Last updated
04.08.2026 22:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
Aptiva

Aptiva® Celiac IgA Disease Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040532
Basic UDI-DI
B-08430793040532
Reference
724120
EMDN
W0102100602
EMDN description
TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 04:15
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aptiva

Aptiva® Celiac Disease IgG Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08430793040471
Basic UDI-DI
B-08430793040471
Reference
724100
EMDN
W0102100602
EMDN description
TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 04:15
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Reagent Kit, DGP IgG

DGP IgG, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030415860
Basic UDI-DI
B-06924030415860
Reference
MY00141C
EMDN
W0102100699
EMDN description
CELIAC DISEASE - OTHER
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Reagent Kit, DGP IgA

DGP IgA, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030415853
Basic UDI-DI
B-06924030415853
Reference
MY00140C
EMDN
W0102100699
EMDN description
CELIAC DISEASE - OTHER
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Reagent Kit, human tTG IgG

human tTG IgG, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030415846
Basic UDI-DI
B-06924030415846
Reference
MY00139C
EMDN
W0102100601
EMDN description
TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Reagent Kit, human tTG IgA

human tTG IgA, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030415839
Basic UDI-DI
B-06924030415839
Reference
MY00138C
EMDN
W0102100601
EMDN description
TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Control Set, DGP IgG

DGP IgG, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030404604
Basic UDI-DI
B-06924030404604
Reference
MY00345
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Control Set, DGP IgA

DGP IgA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030404598
Basic UDI-DI
B-06924030404598
Reference
MY00344
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Control Set, human tTG IgG

human tTG IgG, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030404581
Basic UDI-DI
B-06924030404581
Reference
MY00343
EMDN
W0102100601
EMDN description
TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Control Set, human tTG IgA

human tTG IgA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030404574
Basic UDI-DI
B-06924030404574
Reference
MY00342
EMDN
W0102100601
EMDN description
TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Calibrator Set, DGP IgG

DGP IgG, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030403584
Basic UDI-DI
B-06924030403584
Reference
MY00243
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:01
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Calibrator Set, DGP IgA

DGP IgA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030403577
Basic UDI-DI
B-06924030403577
Reference
MY00242
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:01
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Calibrator Set, human tTG IgG

human tTG IgG, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030403560
Basic UDI-DI
B-06924030403560
Reference
MY00241
EMDN
W0102100601
EMDN description
TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:01
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Calibrator Set, human tTG IgA

human tTG IgA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030403553
Basic UDI-DI
B-06924030403553
Reference
MY00240
EMDN
W0102100601
EMDN description
TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:01
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Reagent Kit, DGP IgG

DGP IgG, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030403072
Basic UDI-DI
B-06924030403072
Reference
MY00192
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 08:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BioCLIA Autoimmune Reagent Kit, DGP IgA

DGP IgA, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
HOB Biotech Group Corp., Ltd.
Manufacturer SRN
CN-MF-000023974
UDI-DI
06924030403065
Basic UDI-DI
B-06924030403065
Reference
MY00191
EMDN
W0102100604
EMDN description
GLIADIN ANTIBODIES
First on market country
Germany
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 08:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details