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PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000410
Basic UDI-DI: 5713915PP004TK
Reference: 1500
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

PlentiPlex™ KIT Mastocytosis qPCR Assay

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000373
Basic UDI-DI: 5713915PP001TD
Reference: 7032
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

XL CDKN2A/9q22

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315812543
Basic UDI-DI: 42513158D-5118IVDKC
Reference: D-5118-100-OG
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 21:52

Manufacturer products View details

ipsogen IDH1 RGQ PCR Kit

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228053262
Basic UDI-DI: 4053228RIDH100000000001BZ
Reference: 675223
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 01.07.2026 19:24

Manufacturer products View details

SALSA MLPA Probemix ME032 UPD7-UPD14

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482427
Basic UDI-DI: 872021148ME032ZH
Reference: ME032-025R
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:44

Manufacturer products View details

SALSA MLPA Probemix P017 MEN1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480317
Basic UDI-DI: 872021148P0175M
Reference: P017-025R
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:42

Manufacturer products View details

EasyPGX ready JAK2

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091290
Basic UDI-DI: 8057289090301CRTX0533Z
Reference: RTX053
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

EasyPGX ready MLH1

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091252
Basic UDI-DI: 8057289090301CRTX0523X
Reference: RTX052
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

EasyPGX ready ESR1

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091245
Basic UDI-DI: 8057289090301CRTX0513V
Reference: RTX051
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

EasyPGX ready NPM1 Quant

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091153
Basic UDI-DI: 8057289090301CRTX04848
Reference: RTX048
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

EasyPGX ready MGMT

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091146
Basic UDI-DI: 8057289090301CRTX0494A
Reference: RTX049
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

EasyPGX ready NPM1 Screening

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091139
Basic UDI-DI: 8057289090301CRTX04746
Reference: RTX047
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:11

Manufacturer products View details

Oncobit PM NRASQ61R Control 10rxn

1.0