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PREP-RAPID GENETICS DNA Extraction Kit

PREP-RAPID DNA Extraction Kits

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362295
Basic UDI-DI: 466001436RA042X2
Reference: P-021/4EU
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-GS PLUS DNA Extraction Kit

PREP-GS DNA Extraction Kits

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362226
Basic UDI-DI: 466001436RA046XA
Reference: P-003/2EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Extraction purification kit of NA for blood 96R IVD

Extraction and purification kit of NA for blood

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: AD Nucleis
Manufacturer SRN: FR-MF-000002215
UDI-DI: 37604277000264
Basic UDI-DI: 376042770112B4
Reference: Kit-EP_96_112_I_PF
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 08:06

Manufacturer products View details

HighPrep Viral DNA & RNA Kit - DX (3840 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030995
Basic UDI-DI: 0850045030HPV-DR3840ERV
Reference: HPV-DR3840E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

HighPrep Viral DNA & RNA Kit - DX (20 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030346
Basic UDI-DI: 0850045030HPV-DR20EMK
Reference: HPV-DR20E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

HighPrep Viral DNA & RNA Kit - DX (384 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030070
Basic UDI-DI: 0850045030HPV-DR96x4E5N
Reference: HPV-DR96x4E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

HighPrep Viral DNA & RNA Kit - DX (96 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030063
Basic UDI-DI: 0850045030HPV-DR96EP8
Reference: HPV-DR96E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

Quick-RNA Viral 96 Kit - DX (2 x 96 preps)

R2140-E

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zymo Research Corp.
Manufacturer SRN: US-MF-000019308
UDI-DI: 00850027600208
Basic UDI-DI: 0850027600R2140FM
Reference: R1040-E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: DAVID Catherine Elisabeth Marie
Last updated: 16.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors View details

ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack)

D4302-E

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zymo Research Corp.
Manufacturer SRN: US-MF-000019308
UDI-DI: 00850027600178
Basic UDI-DI: 0850027600D4032B5
Reference: D4302-E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: DAVID Catherine Elisabeth Marie
Last updated: 16.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors View details

EZ-96 DNA Methylation-Lightning Kit (Deep-Well) - 2 x 96 Rxns

D5033-E

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagent

Manufacturer: Zymo Research Corp.
Manufacturer SRN: US-MF-000019308
UDI-DI: 00850027600062
Basic UDI-DI: 0850027600D5033BE
Reference: D5033-E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: DAVID Catherine Elisabeth Marie
Last updated: 16.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors View details

EZ-96 DNA Methylation-Lightning Kit (Shallow-Well) -2 x 96 Rxns

D5032-E

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagent

Manufacturer: Zymo Research Corp.
Manufacturer SRN: US-MF-000019308
UDI-DI: 00850027600055
Basic UDI-DI: 0850027600D5032BC
Reference: D5032-E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: DAVID Catherine Elisabeth Marie
Last updated: 16.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors View details

EZ DNA Methylation-Lightning Kit (50 Rxns)

D5030-E

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zymo Research Corp.
Manufacturer SRN: US-MF-000019308
UDI-DI: 00850027600017
Basic UDI-DI: 0850027600D5030B8
Reference: D5030-E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: DAVID Catherine Elisabeth Marie
Last updated: 16.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors View details

00850024414068

Veracyte FFPE RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Veracyte, Inc
Manufacturer SRN: US-MF-000048711
UDI-DI: 00850024414068
Basic UDI-DI: 0850024414FFPERNAEXXV
Reference: 550100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Ireland
Authorised representative: Veracyte Global BV
Last updated: 16.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® FFPE Lysis Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940006013
Basic UDI-DI: 081164701-GXFFPE-LYSIS-MP
Reference: GXFFPE-LYSIS-CE-10
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Extraction and purification kit of NA for blood 24R IVD

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: AD Nucleis
Manufacturer SRN: FR-MF-000002215
UDI-DI: 37604277000332
Basic UDI-DI: 376042770112B4
Reference: KIT-EP_24_112_I_PF
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:55

Manufacturer products View details

This device is used to extract DNA/RNA from EDTA blood samples

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: AD Nucleis
Manufacturer SRN: FR-MF-000002215
UDI-DI: 37604277000400
Basic UDI-DI: 376042770112B4
Reference: KIT-EP_14_112_I_PF
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:54

Manufacturer products View details

MagMax

MagMax Dx Viral/Pathogen NA Isolation Kit (A52735, A52736)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Baltics UAB
Manufacturer SRN: LT-MF-000046574
UDI-DI: 10190302019170
Basic UDI-DI: 0190302MagMAXDxDN
Reference: A52735
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 22:50

Manufacturer products View details

MagMax

MagMax Viral/Pathogen II Nucleic Acid Isolation Kit A48383

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Baltics UAB
Manufacturer SRN: LT-MF-000046574
UDI-DI: 10190302018241
Basic UDI-DI: 0190302MVP2TT
Reference: A48383
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 22:50

Manufacturer products View details

Abbott mSample Preparation SystemDNA

06K12-24

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Promega Corporation
Manufacturer SRN: US-MF-000034520
UDI-DI: 00849811004452
Basic UDI-DI: 00849811004452JT
Reference: 06K12-24
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 15.07.2026 22:33

Manufacturer products Authorised representative products Authorised representative actors View details

Abbott mSample Preparation System

04J70-24

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Promega Corporation
Manufacturer SRN: US-MF-000034520
UDI-DI: 00849811004445
Basic UDI-DI: 00849811004445JW
Reference: 04J70-24
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 15.07.2026 22:33

Manufacturer products Authorised representative products Authorised representative actors View details