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11 device results listed.

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SARS-CoV-2 RT-qPCR DETECTION KIT

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: D-KSC2-AB692F
Basic UDI-DI: B-KSC2-AB692F
Reference: KSC2-AB69
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 03:47

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ABility Smart Extract

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

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820126
Basic UDI-DI: 376032282APAN2234K
Reference: AB0030
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: 01.07.2026 15:25

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HLAB27GUARD

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820119
Basic UDI-DI: 376032282CGENHLAB27J6
Reference: AB0022
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

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ThromboGUARD FII FV

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820102
Basic UDI-DI: 376032282CGENF2F5FW
Reference: AB0023
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

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RespiGUARD4plex

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820072
Basic UDI-DI: 376032282DINFSCFRRK
Reference: AB0024
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

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Smart GUARD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820058
Basic UDI-DI: 376032282AINS22176
Reference: AB0096
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

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MTL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820027
Basic UDI-DI: 376032282APANMTLD8
Reference: MTL02AB69
EMDN: W050299
EMDN description: DEVICES FOR SAMPLES TRANSPORT - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

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ABility Smart Extract

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820133
Basic UDI-DI: 376032282APAN2234K
Reference: AB0030
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: 29.06.2026 09:00

Manufacturer products View details

ABility Smart Extract

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820140
Basic UDI-DI: 376032282APAN2234K
Reference: AB0038
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: 29.06.2026 09:00

Manufacturer products View details

ThromboGUARD FII FV

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820157
Basic UDI-DI: 376032282CGENF2F5FW
Reference: AB0040
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:00

Manufacturer products View details

HLAB27GUARD

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820164
Basic UDI-DI: 376032282CGENHLAB27J6
Reference: AB0039
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:00

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