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Lambda Light Chain Reagent Kit（Immunoturbidimetric Assay）

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200175
Basic UDI-DI: B-06942202200175
Reference: 3015896
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Sialic Acid Reagent Kit（Lactate Dehydrogenase Assay）

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239984
Basic UDI-DI: B-06942202239984
Reference: 3015843
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Sialic Acid Reagent Kit（Lactate Dehydrogenase Assay）

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 1x1mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202211485
Basic UDI-DI: B-06942202211485
Reference: 3016084
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Myeloperoxidase Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200984
Basic UDI-DI: B-06942202200984
Reference: 3015939
EMDN: W01021310
EMDN description: MYELOPEROXIDASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Myeloperoxidase Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL, Calibration sample: 5x0.5mL, Control: 2x0.5mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200977
Basic UDI-DI: B-06942202200977
Reference: 3016067
EMDN: W01021310
EMDN description: MYELOPEROXIDASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:55

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

Manufacturer products Authorised representative products Authorised representative actors View details

HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）

R1: 1x60mL, R2: 1x17mL, Calibration sample: 2x0.5mL, Control: 1x0.5mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239229
Basic UDI-DI: B-06942202239229
Reference: 3014895
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）

R1: 3x50mL, R2: 2x25mL, Calibration sample: 0.8mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239311
Basic UDI-DI: B-06942202239311
Reference: 3012551
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

ISOCITRATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）

R1: 4x50mL, R2: 2x25mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202237843
Basic UDI-DI: B-06942202237843
Reference: 3012494
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN A KIT (IMMUNOTURBIDIMETRIC METHOD)

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238710
Basic UDI-DI: B-06942202238710
Reference: 3014908
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN G KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238727
Basic UDI-DI: B-06942202238727
Reference: 3014888
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238734
Basic UDI-DI: B-06942202238734
Reference: 3014907
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

LEUCINE AMINOPEPTIDASE REAGENT KIT（SUBSTRATE HYDROLYSIS）

R1: 4x50mL, R2: 2x25mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202237768
Basic UDI-DI: B-06942202237768
Reference: 3012542
EMDN: W01010122
EMDN description: LEUCINE AMINOPEPTIDASE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）

R1: 4x50mL, R2: 1x50mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239199
Basic UDI-DI: B-06942202239199
Reference: 3012230
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）

R1: 4x50mL, R2: 2x25mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239205
Basic UDI-DI: B-06942202239205
Reference: 3012532
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

LOW DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）

R1: 3x50mL, R2: 2x25mL, Calibration sample: 0.8mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239274
Basic UDI-DI: B-06942202239274
Reference: 3012552
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239397
Basic UDI-DI: B-06942202239397
Reference: 3012495
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202240928
Basic UDI-DI: B-06942202240928
Reference: 3012541
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

MICROALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40mL, R2: 1x10mL, Calibration sample: 5x0.5mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239601
Basic UDI-DI: B-06942202239601
Reference: 3014909
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

MAGNESIUM REAGENT KIT（XYLIDYL BLUE METHOD）

R:5x50mL, Calibration sample: 2mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238925
Basic UDI-DI: B-06942202238925
Reference: 3012540
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details