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DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2.0

GeneScan Standard, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302007085
Basic UDI-DI
0190302A25793SH
Reference
A25793
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
DS-30 Matrix Standard Kit (Dye Set D) Dx

Matrix Standards, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302006637
Basic UDI-DI
0190302A35945ST
Reference
A35945
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
3500 Dx Genetic Analyzer

Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302005937
Basic UDI-DI
0190302TCF00005084L
Reference
4405182 (A27772)
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Ion PGM™ Dx Sequencer

Ion Personal Genome Machine (PGM™) Dx Instrument System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000833
Basic UDI-DI
0190302A25511RB
Reference
4485656
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Polymer Pouch Caps, Dx

Polymer Pouch Cap, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000680
Basic UDI-DI
01903024462785CK
Reference
4462785
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Sequencing Standard BigDye™ Terminator v1.1 Dx

Sequencing Standard, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000673
Basic UDI-DI
01903024462113AU
Reference
4462113
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Polymer Delivery Pump Cleaning Kit Dx

Polymer Delivery Pump Cleaning Kit Dx, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000666
Basic UDI-DI
0190302TCF00005034A
Reference
4461875
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Array Card Spectral Calibration Dye Kit

Array Card Kits, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000444
Basic UDI-DI
0190302TCF0000576DAR
Reference
4432644
EMDN
W02050199
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
384‑Well Region of Interest (ROI) and Background Plates

Region of Interest (ROI) and Background Plates, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000314
Basic UDI-DI
0190302TCF0000576AAK
Reference
4432482
EMDN
W02050199
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
384-Well Spectral Calibration Plate with FAM Dye

Spectral Calibration Plates, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingSingle use
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000284
Basic UDI-DI
0190302TCF0000576BAM
Reference
4432445
EMDN
W02050199
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
RNase P 384-Well Instrument Verification Plate

RNase P Instrument Verification Plates, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingSingle use
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000321
Basic UDI-DI
0190302TCF0000576CAP
Reference
4432500
EMDN
W02050199
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Septa Cathode Buffer Container Dx

Septa Cathode Buffer Container, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000277
Basic UDI-DI
019030244107169T
Reference
4410716
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
96-Well Septa Dx

96-Well Septa, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000260
Basic UDI-DI
019030244107009C
Reference
4410700
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
3500 Dx Series 96-Well Standard Retainer & Base Set

96-Well/384-Well Standard Retainer and Base Set, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000253
Basic UDI-DI
0190302441022797
Reference
4410227
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Conditioning Reagent Dx

Conditioning Reagent, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000246
Basic UDI-DI
01903024409543B8
Reference
4409543
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
3500 Dx Capillary Array 50-cm

Capillary Array 36-cm/50-cm, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000208
Basic UDI-DI
01903024404682AL
Reference
4404684
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Hi-Di™ Formamide Dx (5 mL)

Hi-Di™ Formamide, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000192
Basic UDI-DI
019030244043079P
Reference
4404307 (4440752)
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Anode Buffer Container Dx

Buffer Container, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000185
Basic UDI-DI
01903024408258AX
Reference
4393925
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
POP-7™ Polymer Dx (384 Samples)

POP™ polymer, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Life Technologies Holdings Pte Ltd
Manufacturer SRN
SG-MF-000023931
UDI-DI
10190302000147
Basic UDI-DI
01903024393709CW
Reference
4393709
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Netherlands
Authorised representative
Life Technologies Europe B.V.
Last updated
15.07.2026 22:49
Revogene® Mock Pie

Revogene® Mock Pie

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing
Manufacturer
Meridian Bioscience Inc.
Manufacturer SRN
US-MF-000044096
UDI-DI
00840733102332
Basic UDI-DI
008407331REVOGENECLA003TK
Reference
610208
EMDN
W02050106
EMDN description
DNA GENOMIC PREPARATION DEVICES
First on market country
Italy
Authorised representative
Meridian Bioscience Europe S.r.l.
Last updated
15.07.2026 22:25