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23 device results listed.

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iFlash-Histones IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720324
Basic UDI-DI: 692591270250HA
Reference: C86080G
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiverDot Chromatin IgG

BlueDiver Dot

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681398
Basic UDI-DI: 542502368BDDCHROMATIN6Y
Reference: CHRDIV-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Chromatin IgG

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680568
Basic UDI-DI: 542502368BDCHROMATINFW
Reference: CHRD-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

D-IM4415264K2

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4415264K2
Basic UDI-DI: B-IM4415264K2
Reference: IM4415264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:34

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4414264JT

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4414264JT
Basic UDI-DI: B-IM4414264JT
Reference: IM4414264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411264J6

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411264J6
Basic UDI-DI: B-IM4411264J6
Reference: IM4411264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4410264HX

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4410264HX
Basic UDI-DI: B-IM4410264HX
Reference: IM4410264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

Anti Histone

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147158118
Basic UDI-DI: B-86060147158118
Reference: N717A24HIS
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Histones IgG

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912721215
Basic UDI-DI: 692591270250HA
Reference: C86080G-S
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

08435287148626

ANTI-HISTONES ANTIBODIES (HIS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148626
Basic UDI-DI: B-08435287148626
Reference: 44862
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

QUANTA Lite

QUANTA Lite® Histone ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950506331
Basic UDI-DI: B-08426950506331
Reference: 708520
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Histones IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769321
Basic UDI-DI: B-06975070769321
Reference: 14000723
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Histones IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761288
Basic UDI-DI: B-06975070761288
Reference: 11104007
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403098

IM4410264 IM4411264 IM4414264 IM4415264

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403098
Basic UDI-DI: 69506174IM441264DX
Reference: IM4415264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403081

IM4410264 IM4411264 IM4414264 IM4415264

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403081
Basic UDI-DI: 69506174IM441264DX
Reference: IM4414264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403074

IM4410264 IM4411264 IM4414264 IM4415264

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403074
Basic UDI-DI: 69506174IM441264DX
Reference: IM4411264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

06950617403067

IM4410264 IM4411264 IM4414264 IM4415264

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403067
Basic UDI-DI: 69506174IM441264DX
Reference: IM4410264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDot Chromatin4 IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680896
Basic UDI-DI: 542502368BDCHROMATINFW
Reference: CHR4D-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDiverDot Chromatin4 IgG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681817
Basic UDI-DI: 542502368BDDCHROMATIN6Y
Reference: CHR4DIV-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

NDH Chromatin Dot

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687222
Basic UDI-DI: 542502368BDCHROMATINFW
Reference: AD NDHD
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details