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37 device results listed.

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D-697180825KCL003F3R5

BCR/ABL gene fusion detection kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-697180825KCL003F3R5
Basic UDI-DI: B-697180825KCL003F3R5
Reference: FP-003
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

05061059980366

ZENA MAX BCR/ABL Major Real Time PCR Quantitative Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980366
Basic UDI-DI: B-05061059980366
Reference: KD873977-100
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906518
Basic UDI-DI: 50558449LPH038JQ
Reference: CE-LPH 038-S
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906181
Basic UDI-DI: 50558449LPH007JD
Reference: CE-LPH 007
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

XL BCR/ABL1/ASS

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315812239
Basic UDI-DI: 42513158D-5082IVDL2
Reference: D-5082-100-TC
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:58

Manufacturer products View details

XL BCR/ABL1 plus

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315812093
Basic UDI-DI: 42513158D-5052IVDJZ
Reference: D-5052-100-OG
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:57

Manufacturer products View details

geneMAP

geneMAP BCR-ABL1 (p190, p210, p230) Screening Kit, 48T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405BCRSCRRTF7
Basic UDI-DI: B-TRMF000028405BCRSCRRTF7
Reference: BCRSCR-RT48
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details

geneMAP

geneMAP BCR-ABL1 p230(μbcr) Detection Kit, 48T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405BCR230RTTN
Basic UDI-DI: B-TRMF000028405BCR230RTTN
Reference: BCR230-RT48
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details

geneMAP

geneMAP BCR-ABL1 p210(Mbcr) IS-MMR Detection Kit, 48T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405BCR210RTT8
Basic UDI-DI: B-TRMF000028405BCR210RTT8
Reference: BCR210-RT48
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details

geneMAP

geneMAP BCR-ABL1 p190(mbcr) Detection Kit, 48T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405BCR190RTUM
Basic UDI-DI: B-TRMF000028405BCR190RTUM
Reference: BCR190-RT48
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details

Dr. PCR™ BCR-ABL1 Major IS Detection Kit

DON01-X

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940087
Basic UDI-DI: B-08809740940087
Reference: DON01-X
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

08057723370554

Lyoset P190 Reference

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370554
Basic UDI-DI: B-08057723370554
Reference: LRF-028
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370547

Lyoset P210 Reference

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370547
Basic UDI-DI: B-08057723370547
Reference: LRF-027
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370530

SensiQuant P230 Positive Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370530
Basic UDI-DI: B-08057723370530
Reference: CTRL-040
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370523

SensiQuant P230 Standard

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370523
Basic UDI-DI: B-08057723370523
Reference: STD-040
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370516

SensiQuant Direct P230 Master Mix

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370516
Basic UDI-DI: B-08057723370516
Reference: SQTd-040
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370448

SensiQuant P190 Positive Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370448
Basic UDI-DI: B-08057723370448
Reference: CTRL-028
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370431

SensiQuant Direct P190 MasterMix

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370431
Basic UDI-DI: B-08057723370431
Reference: SQTd-028
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:37

Manufacturer products View details

08057723370424

SensiQuant P210 Positive Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370424
Basic UDI-DI: B-08057723370424
Reference: CTRL-027
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

08057723370417

SensiQuant Direct P210 MasterMix

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370417
Basic UDI-DI: B-08057723370417
Reference: SQTd-027
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details