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996 device results listed.

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IGH Gene Clonality Assay

IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Invivoscribe, Inc.
Manufacturer SRN: US-MF-000011736
UDI-DI: 00850052003159
Basic UDI-DI: B-00850052003159
Reference: 9-101-0081
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Austria
Authorised representative: IN VIVOSCRIBE TECHNOLOGIES
Last updated: 05.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

IGH Gene Clonality Assay

IGH Gene Clonality Assay for ABI Fluorescence Detection

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Invivoscribe, Inc.
Manufacturer SRN: US-MF-000011736
UDI-DI: 00850052003142
Basic UDI-DI: B-00850052003142
Reference: 9-101-0061
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Austria
Authorised representative: IN VIVOSCRIBE TECHNOLOGIES
Last updated: 05.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

00850024414044

Prosigna Breast Cancer Prognostic Gene Signature Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Veracyte, Inc
Manufacturer SRN: US-MF-000048711
UDI-DI: 00850024414044
Basic UDI-DI: B-00850024414044
Reference: PROSIGNA-002; PROSIGNA-003; PROSIGNA-004; PROSIGNA-010
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: France
Authorised representative: Veracyte Global BV
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071500B3PT
Basic UDI-DI: B-0000128071500B3PT
Reference: HWTS-GE010
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Clean Blood & Tissue DNA Kit Dx

CBTDx

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: CleanNA B.V.
Manufacturer SRN: NL-MF-000022870
UDI-DI: 08720299808768
Basic UDI-DI: 87202998087CBT7F
Reference: CBTDx-D0384
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:53

Manufacturer products View details

Laborant Total Nucleic Acid Extraction NS Kit (480)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000033765
UDI-DI: 08683808252097
Basic UDI-DI: 8683808252097CZ
Reference: LE-01-480
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:16

Manufacturer products View details

Laborant Total Nucleic Acid Extraction Kit (96)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000033765
UDI-DI: 08683808252080
Basic UDI-DI: 8683808252080CG
Reference: LE-01-96
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:16

Manufacturer products View details

Laborant Total Nucleic Acid Extraction Kit (48)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000033765
UDI-DI: 08683808252073
Basic UDI-DI: 8683808252073CK
Reference: LE-01-48
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:16

Manufacturer products View details

MULTIGEN

FAST-GBA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GBA Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090409ED
Basic UDI-DI: 8681957090409ED
Reference: M-GBA-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-EXT1/EXT2 NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile EXT1 ve EXT2 Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090393EP
Basic UDI-DI: 8681957090393EP
Reference: M-EXT-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-HFE NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile HFE Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090386ES
Basic UDI-DI: 8681957090386ES
Reference: M-HFE-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-F7 NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile F7 Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090379EV
Basic UDI-DI: 8681957090379EV
Reference: M-F7-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-GAA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GAA Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090362EC
Basic UDI-DI: 8681957090362EC
Reference: M-GAA-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-VWF Yeni Nesil Dizi Analizi ile VWF Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090355EF
Basic UDI-DI: 8681957090355EF
Reference: M-VWF-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-LIPODISTROFI Yeni Nesil Dizi Analizi ile Lipodistrofi Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090331DZ
Basic UDI-DI: 8681957090331DZ
Reference: M-LD-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-GLA Yeni Nesil Dizi Analizi ile GLA Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090325E6
Basic UDI-DI: 8681957090325E6
Reference: M-GLA-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

FAST WILSON SYNDROME Yeni Nesil Dizi Analizi ile ATP7B Mutasyonlarını Saptama Kiti

FAST-TP53 Yeni Nesil Dizi Analizi ile TP53 Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090171E3
Basic UDI-DI: 8681957090201DK
Reference: M-WLS-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

MULTIGEN

FAST-JK2 SEQUENCING KIT

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090119DZ
Basic UDI-DI: 8681957090119DZ
Reference: M-JK-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details

MULTİGEN

NGS Sequencing Kit

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

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090065E3
Basic UDI-DI: 8681957090065E3
Reference: M-FMF-02
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details

MULTIGEN

FAST-mtDNA NGS Sequencing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090027DT
Basic UDI-DI: 8681957090027DT
Reference: M-MT-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details