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456 device results listed.

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FLEX Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5, Ready-to-Use (Dako Omnis)

GA074

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA074613H
Basic UDI-DI: B-USMF000009385GA074613H
Reference: GA07461-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Myogenin, Clone F5D, Ready-to-Use (Dako Omnis)

GA067

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA067613R
Basic UDI-DI: B-USMF000009385GA067613R
Reference: GA06761-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human CD15, Clone Carb-3, Ready-to-Use (Dako Omnis)

GA062

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA062612Y
Basic UDI-DI: B-USMF000009385GA062612Y
Reference: GA06261-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Rabbit Anti-Human AMACR, Clone 13H4, Ready-to-Use (Dako Omnis)

GA060

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA060612N
Basic UDI-DI: B-USMF000009385GA060612N
Reference: GA06061-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38, Ready-to-Use (Dako Omnis)

GA059

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA059613U
Basic UDI-DI: B-USMF000009385GA059613U
Reference: GA05961-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Inhibin α, Clone R1, Ready-to-Use (Dako Omnis)

GA058

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA058613P
Basic UDI-DI: B-USMF000009385GA058613P
Reference: GA05861-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Dako Omnis)

GA054

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA0546133
Basic UDI-DI: B-USMF000009385GA0546133
Reference: GA05461-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3, Ready-to-Use (Dako Omnis)

GA053

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA053612W
Basic UDI-DI: B-USMF000009385GA053612W
Reference: GA05361-2
EMDN: W0102030126
EMDN description: CYTOKERATINS
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Melanosome, Clone HMB-45, Ready-to-Use (Dako Omnis)

GA052

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: D-USMF000009385GA052612R
Basic UDI-DI: B-USMF000009385GA052612R
Reference: GA05261-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

HercepTest for Automated Link Platforms

SK001

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448SK00121A2
Basic UDI-DI: B-SGMF000014448SK00121A2
Reference: SK00121-2
EMDN: W0102030301
EMDN description: HER-2/NEU
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

HER2 IQFISH pharmDx

K5731

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448K573111Y5
Basic UDI-DI: B-SGMF000014448K573111Y5
Reference: K573111-2
EMDN: W01060213
EMDN description: HER-2/NEU (BREAST CANCER)
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

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

IR786

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR78661CV
Basic UDI-DI: B-SGMF000014448IR78661CV
Reference: IR78661-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6, Clone D5/16 B4, Ready-to-Use (Link)

IR780

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR78061BX
Basic UDI-DI: B-SGMF000014448IR78061BX
Reference: IR78061-2
EMDN: W0102030126
EMDN description: CYTOKERATINS
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Placental Alkaline Phosphatase, Clone 8A9, Ready-to-Use (Link)

IR779

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR77961D5
Basic UDI-DI: B-SGMF000014448IR77961D5
Reference: IR77961-2
EMDN: W0102039005
EMDN description: HUMAN PLACENTA LIKE ALKALINE PHOSPHATASE
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Cytokeratin 20, Clone Kₛ20.8, Ready-to-Use (Link)

IR777

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR77761CT
Basic UDI-DI: B-SGMF000014448IR77761CT
Reference: IR77761-2
EMDN: W0102030126
EMDN description: CYTOKERATINS
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clones CCH2 + DDG9, Ready-to-Use (Link)

IR752

IVD Annex II List BIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR75261BL
Basic UDI-DI: B-SGMF000014448IR75261BL
Reference: IR75261-2
EMDN: W0105040201
EMDN description: CMV ANTIGEN
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen, Clones 2B11 + PD7/26, Ready-to-Use (Link)

IR751

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR75161BF
Basic UDI-DI: B-SGMF000014448IR75161BF
Reference: IR75161-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human p63 Protein, Clone DAK-p63, Ready-to-Use (Link)

IR662

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR66261BG
Basic UDI-DI: B-SGMF000014448IR66261BG
Reference: IR66261-2
EMDN: W0102030125
EMDN description: CANCER ANTIGEN P63
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human Synaptophysin, Clone DAK-SYNAP, Ready-to-Use (Link)

IR660

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR66061B6
Basic UDI-DI: B-SGMF000014448IR66061B6
Reference: IR66061-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

FLEX Monoclonal Mouse Anti-Human MUC2, Clone CCP58, Ready-to-Use (Link)

IR658

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: D-SGMF000014448IR65861C7
Basic UDI-DI: B-SGMF000014448IR65861C7
Reference: IR65861-2
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 13.10.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details