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04260153753741

Allergen Discs Honig

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153753741
Basic UDI-DI: B-04260153753741
Reference: 37106333
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:51

Manufacturer products View details

04260153753338

Allergen Discs Karpfen

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153753338
Basic UDI-DI: B-04260153753338
Reference: 37106233
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:50

Manufacturer products View details

04260153752928

Allergen Discs Banane

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153752928
Basic UDI-DI: B-04260153752928
Reference: 37106092
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:50

Manufacturer products View details

04260153752508

Allergen Discs Kohl

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153752508
Basic UDI-DI: B-04260153752508
Reference: 37601039
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:50

Manufacturer products View details

04260153751686

Allergen Discs Hundeschuppen

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153751686
Basic UDI-DI: B-04260153751686
Reference: 37105005
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:50

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AccuDiag™ Human Specific IgE (20 Perennial Allergens)

Allergy Immunoblot Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Diagnostic Automation/ Cortez Diagnostics, Inc.
Manufacturer SRN: US-MF-000051963
UDI-DI: 00850049545655
Basic UDI-DI: B-00850049545655
Reference: 5253-8
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 05.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

AccuDiag™ Human Specific IgE (20 Atopic Allergens)

Allergy Immunoblot Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Diagnostic Automation/ Cortez Diagnostics, Inc.
Manufacturer SRN: US-MF-000051963
UDI-DI: 00850049545648
Basic UDI-DI: B-00850049545648
Reference: 5151-8
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 05.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

AccuDiag™ Human Specific IgE (20 Food Allergens)

Allergy Immunoblot Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Diagnostic Automation/ Cortez Diagnostics, Inc.
Manufacturer SRN: US-MF-000051963
UDI-DI: 00850049545204
Basic UDI-DI: B-00850049545204
Reference: 5152-8
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 05.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

MosaiQ® Allergy Bet v 1

4x85

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: AliveDx Suisse SA
Manufacturer SRN: CH-MF-000024025
UDI-DI: 07640327463015
Basic UDI-DI: 764032746BETV1MAGAZINER3
Reference: 172001
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

ImmunoCAP Specific IgE Curve Control Strip

ImmunoCAP Specific IgE

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019734
Basic UDI-DI: 7333066BUDI0005LQ
Reference: 10-9312-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

ImmunoCAP Specific IgE Conjugate 400

ImmunoCAP Specific IgE

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019727
Basic UDI-DI: 7333066BUDI0010LH
Reference: 10-9310-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

ImmunoCAP Phadiatop Infant

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066004044
Basic UDI-DI: 7333066BUDI0070M3
Reference: 14-4510-35
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

ImmunoCAP Specific IgE Anti-IgE

ImmunoCAP Specific IgE

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066003733
Basic UDI-DI: 7333066BUDI0065MA
Reference: 14-4417-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

ImmunoCAP Phadiatop

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066003726
Basic UDI-DI: 7333066BUDI0068MG
Reference: 14-4405-35
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

ImmunoCAP Allergen sx1, Inhalativer Allergie Test

ImmunoCAP Allergen

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066003115
Basic UDI-DI: 7333066BUDI0021LN
Reference: 14-4332-35
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

ImmunoCAP Allergen k75, Isocyanate TDI

ImmunoCAP Allergen

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066002965
Basic UDI-DI: 7333066BUDI0022LQ
Reference: 14-4311-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

ImmunoCAP Allergen h1, House dust (Greer Labs. Inc.)

ImmunoCAP Allergen

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066001227
Basic UDI-DI: 7333066BUDI0050LV
Reference: 14-4116-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

ImmunoCAP Allergen e1, Cat dander

ImmunoCAP Allergen

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066001166
Basic UDI-DI: 7333066BUDI0019M3
Reference: 14-4109-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

ImmunoCAP Allergen m2, Cladosporium herbarum

ImmunoCAP Allergen

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066001128
Basic UDI-DI: 7333066BUDI0018LZ
Reference: 14-4105-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

ImmunoCAP Allergen g6, Timothy

ImmunoCAP Allergen

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066001074
Basic UDI-DI: 7333066BUDI0017LX
Reference: 14-4100-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details