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FIT AA01 Specimen Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274139376
Basic UDI-DI: 4987274W01019001SPD026H
Reference: 913937
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

FIT NS-Prime Specimen Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274108747
Basic UDI-DI: 4987274W01019001SPD016F
Reference: 910874
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

CatFlux Solutions

CatFlux Solutions for the CatSper Test, CatFlux Control and Test Solution

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Truion GmbH
Manufacturer SRN: DE-MF-000034807
UDI-DI: 04270003742504
Basic UDI-DI: 42700037425CATfluxGN
Reference: P1001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:47

Manufacturer products View details

- deltaPREP Blood DNA Kit – PP Mini (MDX) Strip 96 rxn

deltaPREP Blood DNA Kit – PP Mini (MDX)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375225068
Basic UDI-DI: 4262375220058R
Reference: 31-DP-7000096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

PurePrep Path DX Kit (96 rxn)

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375224047
Basic UDI-DI: 4262375220048P
Reference: MGV000483
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (96 rxn) Sprips

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375223033
Basic UDI-DI: 4262375220038M
Reference: 31-DP-5010096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (96 rxn) stripes

deltaPREP Blood DNA Mini Kit – IPC16 (MDX)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375222036
Basic UDI-DI: 4262375220028K
Reference: 31-DP-5000096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

- deltaPREP Blood DNA Kit – PP Mini (MDX) Strip 16 rxn

deltaPREP Blood DNA Kit – PP Mini (MDX)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375225051
Basic UDI-DI: 4262375220058R
Reference: 31-DP-7000016
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX) (480 rxn)

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375224023
Basic UDI-DI: 4262375220048P
Reference: 31-DP-2000480
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn) Plates

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375223026
Basic UDI-DI: 4262375220038M
Reference: 31-DP-4010016
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (16 rxn) Plates

deltaPREP Blood DNA Mini Kit – IPC16 (MDX)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375222029
Basic UDI-DI: 4262375220028K
Reference: 31-DP-4000016
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

deltaPREP Blood DNA Kit – PP Mini (MDX) Plate 96 rxn

deltaPREP Blood DNA Kit – PP Mini (MDX)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375225020
Basic UDI-DI: 4262375220058R
Reference: 31-DP-6000096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX) (96 rxn)

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375224016
Basic UDI-DI: 4262375220048P
Reference: 31-DP-2000096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn)

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375223019
Basic UDI-DI: 4262375220038M
Reference: 31-DP-5010016
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

deltaPREP Blood DNA Mini Kit – IPC16 (MDX)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375222012
Basic UDI-DI: 4262375220028K
Reference: 31-DP-5000016
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

PD DETECT I

PD DETECT

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: AIDA GmbH
Manufacturer SRN: DE-MF-000040784
UDI-DI: 04260158683500
Basic UDI-DI: 42601586PDDETECTSE
Reference: SAA-001_20
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

ABX Pentra Clean-Chem 99 CP

A11A01755

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005552
Basic UDI-DI: 361023pentra_clean_chemHQ
Reference: A11A01789
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

ABX Pentra Etching CP

A11A01769

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005514
Basic UDI-DI: 361023pentra_etchingNN
Reference: A11A01769
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

ABX Pentra Clean-Chem CP

A11A01755

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005491
Basic UDI-DI: 361023pentra_clean_chemHQ
Reference: A11A01755
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

ABX Pentra Deproteinizer CP

A11A01754

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005484
Basic UDI-DI: 361023pentra_deprotHD
Reference: A11A01754
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details