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β-Hydroxybutyrate (BHB) Assay

β-Hydroxybutyrate Assay

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Diazyme Laboratories, Inc.
Manufacturer SRN: US-MF-000025166
UDI-DI: 00817089023147
Basic UDI-DI: 0817089023147XE
Reference: DZ153A-KY1
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 11.08.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

β-Hydroxybutyrate Assay

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Diazyme Laboratories, Inc.
Manufacturer SRN: US-MF-000025166
UDI-DI: 00817089023819
Basic UDI-DI: 0817089023147XE
Reference: 10581948190
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 10.08.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 4x50ml, R2: 1x50ml

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239045
Basic UDI-DI: B-06942202239045
Reference: 3012242
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

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α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 2x60mL, R2: 2x15mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260605
Basic UDI-DI: B-06942202260605
Reference: 232013202010
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:27

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α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 4x50mL, R2: 2x25mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202260599
Basic UDI-DI: B-06942202260599
Reference: 232013202014
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 4x50mL, R2: 1x50mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202246975
Basic UDI-DI: B-06942202246975
Reference: 232013202007
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 4x40mL, R2: 4x10mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239038
Basic UDI-DI: B-06942202239038
Reference: 232013202011
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 4x50mL, R2: 1x50mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202215988
Basic UDI-DI: B-06942202215988
Reference: 3023576
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 4x50mL, R2: 1x50mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202215971
Basic UDI-DI: B-06942202215971
Reference: 3023554
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:48

Manufacturer products Authorised representative products Authorised representative actors View details

α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）

R1: 4x50mL, R2: 1x50mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794592071
Basic UDI-DI: B-06925794592071
Reference: 3021599
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

α-Hydroxybutyrate Dehydrogenase Kit (DGKC Method)

105-000819-00、105-000858-00、105-004596-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024752
Basic UDI-DI: 694490400041a-HBDH*****EM
Reference: 105-000819-00
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem HBDH

AutoChem analyzer

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253005941
Basic UDI-DI: 69422530000062NL
Reference: 360105HBD000S
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC)

R1:20mL×4 R2:5mL×4（710）