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186 device results listed.

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Antigen Retrieval Chamber High Voltage

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627035509
Basic UDI-DI: 08476270BARCLN
Reference: DCARC0003
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Antigen Retrieval 2 (AR2), low pH

Oncore Pro Antigen Retrieval Systems

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627031853
Basic UDI-DI: 08476270BOPAGRETYX
Reference: OPRI6005T60
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Dewax Solution Kit

Dewaxing Reagents of IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627031846
Basic UDI-DI: 08476270BDEWAXH2
Reference: OPRI6004KT60
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

PRAME [EPR20330], 0.1mL

PRAME [EPR20330]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627025043
Basic UDI-DI: 08476270B325277
Reference: ACI3252A
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

ONCORE Pro Wash Buffer

Wash Buffers for IHC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627014511
Basic UDI-DI: 08476270BWASHBUF3Q
Reference: OPRI6012MM
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

CAT Hematoxylin, 1 gal

Hematoxylin

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627014252
Basic UDI-DI: 08476270BCHEMATH6
Reference: CATHE-GL
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Borg Decloaker, RTU

Antigen Retrieval Reagents for IHC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627014191
Basic UDI-DI: 08476270BAGRETFS
Reference: BD1000G1
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

intelliPATH FLX™ Peroxidase Blocking Reagent

Peroxidase Blocking Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627008800
Basic UDI-DI: 08476270BPERBLKRZ9
Reference: IPB5000G20
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aqua DePar, 10X

Aqua Depar

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627014184
Basic UDI-DI: 08476270BDEPARFK
Reference: ADP1002 M
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Antibody Diluent

Antibody Diluents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627008244
Basic UDI-DI: 08476270BABDILCD
Reference: FAD901L
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Vulcan Fast Red Chromogen Kit 2, 5mL

Warp Red Chromogen Kits for IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627008275
Basic UDI-DI: 08476270BWR806J6
Reference: FR805-5L
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

MACH 4 MR Universal AP Detection System

MACH Mirco-Polymer Detection System for IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005175
Basic UDI-DI: 08476270BMACH421JC
Reference: BRI4005L
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Background Punisher

Protein Blocking Reagents for IHC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005120
Basic UDI-DI: 08476270BBP974B7
Reference: BP974H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Betazoid DAB Chromogen Kit

Betazoid DAB Chromogen Kits for IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005076
Basic UDI-DI: 08476270BBDB200486
Reference: BDB2004H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

4plus Universal AP Detection

LSAB (Streptavidin) Detection Systems for IHC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003812
Basic UDI-DI: 08476270BLSABKE
Reference: AP506US
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Avidin-Biotin Kit, 25mL

Avidin-Biotin Blocking Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002488
Basic UDI-DI: 08476270BAVBKBRL6
Reference: AB972H
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Carezyme III: Pronase Kit, 25mL

Enzyme Retrieval Reagents for IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627001269
Basic UDI-DI: 08476270BENZRETRS
Reference: PRT957KH
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

intelliPATH FLX™ Universal Negative Control, 20mL

Negative Control Systems for IНС

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627008770
Basic UDI-DI: 8476270BNEGCNTZH
Reference: IP498G20
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 15:20

Manufacturer products Authorised representative products Authorised representative actors View details

Reveal Decloaker, RTU

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627014597
Basic UDI-DI: 08476270BAGRETFS
Reference: RV1000MMRTU
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 20.06.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Tris Buffer Saline (TBS) Plus, 10X

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627014610
Basic UDI-DI: 08476270BWASHBUF3Q
Reference: TBS942M
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 20.06.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details