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94 device results listed.

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RespDirect Collection Kit

Collection, Transport and Lysis Kits

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 25420045515687
Basic UDI-DI: 54200455DIAGCOLLECTVT
Reference: PRD-07403
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 25.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

Hologic Direct Load Capture Cap Collection Kits – CLASSIQSwabs

Collection, Transport and Lysis Kits

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 25420045514345
Basic UDI-DI: 54200455DIAGCOLLECTVT
Reference: PRD-06951
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 25.07.2026 01:48

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Aptima Multitest Swab Specimen Collection Kit

Collection, Transport and Lysis Kits

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 25420045510187
Basic UDI-DI: 54200455DIAGCOLLECTVT
Reference: PRD-03546
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 24.07.2026 23:02

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Aptima CMV Quant Assay Controls Kit

Aptima CMV Quant Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514584
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05076
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 17.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CMV Quant Assay Target Enhancer Reagent

Aptima CMV Quant Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514560
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05077
EMDN: W0105040299
EMDN description: CMV REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 17.07.2026 05:31

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Panther Fusion GI Expanded Bacterial Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517509
Basic UDI-DI: 54200455DIAGPFGIEXPBACUK
Reference: PRD-07121
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

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Panther Fusion GI Bacterial Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517486
Basic UDI-DI: 54200455DIAGPFGIBACUY
Reference: PRD-07113
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima SARS-CoV-2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045516991
Basic UDI-DI: 54200455DIAGAPTSARSCOV2CC
Reference: PRD-07881
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CMV Quant Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514553
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05074
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Assay Fluids

Reagents and Fluids

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500280
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: 303014
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima SARS-CoV-2 Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517004
Basic UDI-DI: 54200455DIAGAPTSARSCOV2CC
Reference: PRD-07881
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 09.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima SARS-CoV-2 Assay Controls Kit

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517035
Basic UDI-DI: 54200455DIAGAPTSARSCOV2CC
Reference: PRD-07882
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 09.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Reconstitution Buffer I

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509252
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04333
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Extraction Reagent-S

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509214
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04331
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Elution Buffer

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509269
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04334
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Reconstitution Buffer II

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510456
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04804
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Open Access RNA/DNA Enzyme Cartridge

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045515451
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04303
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Extraction Reagent-X

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510463
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04477
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Oil

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509276
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04335
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Open Access Diluent Additive

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045511071
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04945
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details