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102 device results listed.

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Helicobacter pylori IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002364
Basic UDI-DI: B-04049325002364
Reference: RE56391
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

Helicobacter pylori IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002357
Basic UDI-DI: B-04049325002357
Reference: RE56381
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

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Helicobacter pylori IgA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002340
Basic UDI-DI: B-04049325002340
Reference: RE56371
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

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K-ASSAY H. pylori Calibrator

H. pylori Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021143
Basic UDI-DI: B-00816426021143
Reference: KAI-241C
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY H. pylori

H. pylori Test Reagent

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021136
Basic UDI-DI: B-00816426021136
Reference: KAI-240
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

GAP IgM Helicobacter pylori ELISA

7006

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059070064
Basic UDI-DI: B-00083059070064
Reference: 7006
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

CHORUS HELICOBACTER PYLORI IgA

CHORUSPYA

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322403
Basic UDI-DI: 803389132CHORUSPYA00C7
Reference: 81062
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

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CHORUS HELICOBACTER PYLORI IgG

CHORUSPYG

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322397
Basic UDI-DI: 803389132CHORUSPYG00D5
Reference: 81060
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

H. pylori Antibody Rapid Test

Format (cassette): A4A411125, A4A411140, A4A411225, A4A411240 Format (strip): A4A410150, A4A410250

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804831967
Basic UDI-DI: 69528048A4A41105L
Reference: Format (cassette): A4A411;Format (strip): A4A410
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip