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137 device results listed.

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AccuDiagTM Total Human IgE

Allergy ELISA Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Diagnostic Automation/ Cortez Diagnostics, Inc.
Manufacturer SRN: US-MF-000051963
UDI-DI: 00850054026477
Basic UDI-DI: B-00850054026477
Reference: 1801-18
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Austria
Authorised representative: AR Experts B.V.
Last updated: 05.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Evo Total SPA

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testing

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 48058945154456
Basic UDI-DI: 8058945151N3100TOTCL
Reference: 1N3100 TOT20
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:18

Manufacturer products View details

Evo Total E

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155769
Basic UDI-DI: 8058945151N110098ZV
Reference: 1N1100 98
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

Evo Total E

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155752
Basic UDI-DI: 8058945151N110020YQ
Reference: 1N1100 20
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

ImmunoCAP Total IgE Curve Control Strip

ImmunoCAP Total IgE

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019789
Basic UDI-DI: 7333066BUDI0060LY
Reference: 10-9325-01
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

ImmunoCAP Total IgE Conjugate 100

ImmunoCAP Total IgE

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019772
Basic UDI-DI: 7333066BUDI0059MF
Reference: 10-9319-01
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

ImmunoCAP Total IgE Anti-IgE

ImmunoCAP Total IgE

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066004037
Basic UDI-DI: 7333066BUDI0062M4
Reference: 14-4509-01
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

ImmunoCAP Total IgE Low Range

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066003986
Basic UDI-DI: 7333066BUDI0069MJ
Reference: 14-4497-35
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

06973224897333

30 Tests/kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224897333
Basic UDI-DI: 6973224890066AQ
Reference: DC76106
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-020853-00、105-002240-00、105-002241-00、105-020854-00、105-004501-00、105-004502-00、105-002309-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986827
Basic UDI-DI: 69449040004JIgE********W8
Reference: 105-020853-00
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

IGE

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309086924
Basic UDI-DI: 5204309000029P2
Reference: 1418-0800
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

Total Immunoglobulin E (IgE)

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590701727
Basic UDI-DI: 150995901C22529QK
Reference: C22529
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

tIgE CLIA Microparticles

Autolumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150906603
Basic UDI-DI: 697015090000053H5
Reference: CMQ0602
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL IgE (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798364
Basic UDI-DI: B-06954414798364
Reference: /
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792164
Basic UDI-DI: B-06954414792164
Reference: /
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453482
Basic UDI-DI: 69506174IM440454DX
Reference: IM4403454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453475
Basic UDI-DI: 69506174IM440454DX
Reference: IM4407454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453468
Basic UDI-DI: 69506174IM440454DX
Reference: IM4402454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453451
Basic UDI-DI: 69506174IM440454DX
Reference: IM4406454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E (IgE) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334822950
Basic UDI-DI: B-06950334822950
Reference: 32027218
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:45

Manufacturer products Authorised representative products Authorised representative actors View details