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832 device results listed.

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Chlamydia pn. IgG Control

Chlamydia pn. IgG Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesInstrumentKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738145
Basic UDI-DI: 692591270316HF
Reference: CC1021
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

POLYVALENT POSITIVE CONTROL

POLYVALENT POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013104
Basic UDI-DI: 5032384StrepGroupPC2K
Reference: DR0592G
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE

IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384503032
Basic UDI-DI: 5032384ImagenSlideChlamB5
Reference: S610930-2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

IMAGEN HSV POSITIVE CONTROL SLIDE

IMAGEN HSV POSITIVE CONTROL SLIDE

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384503049
Basic UDI-DI: 5032384ImagenSlideHSVP2
Reference: S611030-2
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODXTRA POSITIVE CONTROL

PATHODXTRA POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519897
Basic UDI-DI: 5032384PathoDxtraPCFJ
Reference: DR0707G
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX HERPES TYPING CONTROL SLIDES

PATHODX HERPES TYPING CONTROL SLIDES

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500010
Basic UDI-DI: 50560805PathoDXSlideHSV2N
Reference: R62251
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)

SEROLOGY HBeAg POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217933
Basic UDI-DI: 50552732BHBPOCT140DS
Reference: SR10459
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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SEROLOGY HIV-1 P24Ag POSITIVE CONTROL (HIV-1 P24Ag CONTROL +)

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217100
Basic UDI-DI: 50552732BAGPOCO125AR
Reference: SR10458
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL NEGATIVE)

SEROLOGY CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216493
Basic UDI-DI: 50552732BSECONT122LA
Reference: SR10351
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)

SEROLOGY ToRCH CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216400
Basic UDI-DI: 50552732BSETECO123LF
Reference: SR10347
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)

SEROLOGY LYME DISEASE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216387
Basic UDI-DI: 50552732BSELYDC124N4
Reference: SR10345
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

993-04201, 997-04101, 995-04401

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481163829
Basic UDI-DI: 498748114987481163802ZB
Reference: 995-04401
EMDN: W0105080806
EMDN description: MYCOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

Standard Gas

IVD Class BIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987035485513
Basic UDI-DI: 498703502SG460644FU
Reference: UB-SP-012
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0262

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357004717
Basic UDI-DI: 0845357002629L
Reference: [0262U] KWIK-STIK™ S. marcescens ATCC 43862™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0156

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357001600
Basic UDI-DI: 0845357001569L
Reference: [0156L] LYFO DISK™ M. hominis ATCC 15488™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0151

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357001457
Basic UDI-DI: 0845357001519A
Reference: [0151L] LYFO DISK™ U. parvum ATCC 27813™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

BACTERIAL ANTIGENS

No

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673252113
Basic UDI-DI: B-08431673252113
Reference: 1205211
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details

BACTERIAL ANTIGENS

No

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673252014
Basic UDI-DI: B-08431673252014
Reference: 1205201
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details

LIAISON® Control QuantiFERON®-TB Gold Plus II

LIAISON® Control QuantiFERON®-TB Gold Plus II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104463
Basic UDI-DI: 805677131109142
Reference: 311091
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® MUREX Control Anti-HEV IgM

LIAISON® MUREX Control Anti-HEV IgM

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103923
Basic UDI-DI: 805677131128149
Reference: 311281
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details