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769 device results listed.

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MAGLUMI EBV EA IgG (CLIA) Controls

EBV EA IgG (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145539900
Basic UDI-DI: 694714551001HE
Reference: 1602011001MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI H.pylori IgM (CLIA) Controls

H.pylori IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145523404
Basic UDI-DI: 694714551015HR
Reference: 1602011015MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Antigens Negative Control

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958876
Basic UDI-DI: 59026439BRTK868QZ
Reference: 1-868-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Respiratory Antigens Negative Control

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958869
Basic UDI-DI: 59026439BRTK867QX
Reference: 1-867-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna Cryptosporidium

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958852
Basic UDI-DI: 59026439BRTK829QP
Reference: 1-829-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna H. pylori Ag

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958845
Basic UDI-DI: 59026439BRTK827QK
Reference: 1-827-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna C. difficile Tox. B

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958838
Basic UDI-DI: 59026439BRTK826QH
Reference: 1-826-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

Kontrola pozytywna C. difficile Tox. A

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958821
Basic UDI-DI: 59026439BRTK825QF
Reference: 1-825-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna C. difficile GDH

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958814
Basic UDI-DI: 59026439BRTK824QD
Reference: 1-824-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna RSV

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958791
Basic UDI-DI: 59026439BRTK822Q9
Reference: 1-822-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna Norovirus GII

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958784
Basic UDI-DI: 59026439BRTK821Q7
Reference: 1-821-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna Norovirus GI

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958777
Basic UDI-DI: 59026439BRTK820Q5
Reference: 1-820-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna Influenza A+B

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958760
Basic UDI-DI: 59026439BRTK819QL
Reference: 1-819-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna Campylobacter

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958753
Basic UDI-DI: 59026439BRTK818QJ
Reference: 1-818-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Kontrola pozytywna Rotavirus

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958746
Basic UDI-DI: 59026439BRTK817QG
Reference: 1-817-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

Kontrola pozytywna Adenovirus

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958739
Basic UDI-DI: 59026439BRTK816QE
Reference: 1-816-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details

Kontrola pozytywna Giardia

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958722
Basic UDI-DI: 59026439BRTK815QC
Reference: 1-815-0001
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

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Panther Fusion Internal Control-S

Panther Fusion Internal Control Reagents

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509221
Basic UDI-DI: 54200455DIAGPFINTCTRLWV
Reference: PRD-04332
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Controls Kit

Aptima Controls Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045506237
Basic UDI-DI: 54200455DIAGAPTCTGCCTRL4X
Reference: 301110
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST TB LAM Ag Control

PATHFAST TB LAM Ag Conttrol

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301940
Basic UDI-DI: 4987595PF0231CWP
Reference: 30194
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: PHC Europe B.V.
Last updated: 02.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details