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AURYX 90 Buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601530
Basic UDI-DI: 59075146I20-C0002_5B4
Reference: I20-C0002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:22

Manufacturer products View details

AURYX 90 Auffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601516
Basic UDI-DI: 59075146I20-C0001_4AV
Reference: I20-C0001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:22

Manufacturer products View details

Calibration plate

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280070
Basic UDI-DI: 574400328CALIB46
Reference: RLA216
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use (Dako Omnis)

GA786/IR786

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004577
Basic UDI-DI: 570057R0301P3007C008701NK
Reference: GA786
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis)

GA785

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004560
Basic UDI-DI: 570057R0301P3007C015701N9
Reference: GA785
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use (Dako Omnis)

GA784

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004553
Basic UDI-DI: 570057R0301P3007C008601NE
Reference: GA784
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis)

GA783

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004546
Basic UDI-DI: 570057R0301P3007C008501N9
Reference: GA783
EMDN: W0102030124
EMDN description: CANCER ANTIGEN P16
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use (Dako Omnis)

GA087/IR087

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004508
Basic UDI-DI: 570057R0301P3007C057901QD
Reference: GA087
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Rabbit Anti-Human MSH6, Clone EP49 Ready-to-Use (Dako Omnis)

GA086/IR086

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004492
Basic UDI-DI: 570057R0301P3007C057801Q8
Reference: GA086
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use (Dako Omnis)

GA085/IR085

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573004485
Basic UDI-DI: 570057R0301P3007C057701Q3
Reference: GA085
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human MLH1, Clone ES05 Ready-to-Use (Dako Omnis)

GA079/IR079

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700573003730
Basic UDI-DI: 570057R0301P3007C057601PW
Reference: GA079
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

PD-L1 Control Slides

T1391

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700573001736
Basic UDI-DI: 570057P3007P3010A054501P6
Reference: T1391
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:53

Manufacturer products Authorised representative products Authorised representative actors View details

Envision FLEX DAB Enhancer (Dako Omnis)

GC806

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700573001309
Basic UDI-DI: 570057P3007P3010A029401P3
Reference: GC806
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:53

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Calretinin, Clone DAK-Calret 1, Ready-to-Use (Dako Omnis)

GA627/IR627

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700572034230
Basic UDI-DI: 570057R0301P3007C009401NB
Reference: GA627
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:53

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human CD56, Clone 123C3, Ready-to-Use (Dako Omnis)

GA628

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700572033363
Basic UDI-DI: 570057R0301P3007C009301N6
Reference: GA628
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein, Clone 124, Ready-to-Use (Dako Omnis)

GA614/IR614

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700572033127
Basic UDI-DI: 570057R0301P3007C009101MU
Reference: GA614
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Melan-A, Clone A103, Ready-to-Use (Dako Omnis)

GA633/IR633

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700572033028
Basic UDI-DI: 570057R0301P3007C009501NG
Reference: GA633
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

EnVision FLEX Mini Kit, High pH (Link)

K802321-2

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700572030997
Basic UDI-DI: 570057P3007P3010A025201MV
Reference: K8023
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

EnVision FLEX+ Mouse (LINKER) (Link)

K802121-2

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700572030676
Basic UDI-DI: 570057P3007P3010A025101MQ
Reference: K8021
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

EnVision Flex+ Rabbit (LINKER) (Link)

K800921-2

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700572030614
Basic UDI-DI: 570057P3007P3010A025001MK
Reference: K8009
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details