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108 device results listed.

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HPV Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCHPV-S9G
Basic UDI-DI: B-SCHPV-S9G
Reference: SCHPV-S
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Ag Control

H.pylori Ag Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCHPG-S75
Basic UDI-DI: B-SCHPG-S75
Reference: SCHPG-S
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Human Metapneumovirus Antigen Control

Human Metapneumovirus Antigen Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCHMPV-D-LU5
Basic UDI-DI: B-SCHMPV-D-LU5
Reference: SCHMPV-D-L
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B+H1N1 Combo Control

Influenza A/B+H1N1 Combo Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCFABH-SNF
Basic UDI-DI: B-SCFABH-SNF
Reference: SCFABH-S
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba/Giardia/Crypto Control

Entamoeba/Giardia/Crypto Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCEGC-L33
Basic UDI-DI: B-SCEGC-L33
Reference: SCEGC-L
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba/Giardia/Crypto Control

Entamoeba/Giardia/Crypto Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCEGC-D-LBJ
Basic UDI-DI: B-SCEGC-D-LBJ
Reference: SCEGC-D-L
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/IgM Antibody Control

Chikungunya IgG/IgM Antibody Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCCHI-D-LCX
Basic UDI-DI: B-SCCHI-D-LCX
Reference: SCCHI-D-L
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCCHA-DZP
Basic UDI-DI: B-SCCHA-DZP
Reference: SCCHA-D
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Control

Dengue IgG/IgM Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCDEGM-LQF
Basic UDI-DI: B-SCDEGM-LQF
Reference: SCDEGM-L
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium Antigen Control

Cryptosporidium Antigen Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCCRY-D-LNH
Basic UDI-DI: B-SCCRY-D-LNH
Reference: SCCRY-D-L
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella Abortus Control

Brucella Abortus Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCBA-D-LFD
Basic UDI-DI: B-SCBA-D-LFD
Reference: SCBA-D-L
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 Control

BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020174
Basic UDI-DI: B-06419587020174
Reference: 602017
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Positive Control Flu

Positive Control Flu

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815071110
Basic UDI-DI: B-04987815071110
Reference: ACPC7111
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Latvia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella typhi and paratyphi Antigen Control

Salmonella typhi and paratyphi Antigen Control

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-SCSTP-DC9
Basic UDI-DI: B-SCSTP-DC9
Reference: SCSTP-D
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 23.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

ZIKA IgG Control

ZIKA IgG Control

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-SCZIBG-DY8
Basic UDI-DI: B-SCZIBG-DY8
Reference: SCZIBG-D
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 15.07.2026 05:40

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag Control Kit

GCHP-PN2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHP-PN2HG9F
Basic UDI-DI: B-GCHP-PN2HG9F
Reference: GCHP-PN2
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM CONTROL Kit

GCCOV-PN10，GCCOV-PN20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-PNN4
Basic UDI-DI: B-GCCOV-PNN4
Reference: GCCOV-PN10，GCCOV-PN20
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM CONTROL Kit

GCCOV-PN20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-PN20HGJA
Basic UDI-DI: B-GCCOV-PN20HGJA
Reference: GCCOV-PN20
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM CONTROL Kit

GCCOV-PN10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-PN10HGJ3
Basic UDI-DI: B-GCCOV-PN10HGJ3
Reference: GCCOV-PN10
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Control Kit

GCCOV(Ag)-PN10，GCCOV(Ag)-PN20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV(Ag)-PNF6
Basic UDI-DI: B-GCCOV(Ag)-PNF6
Reference: GCCOV(Ag)-PN10，GCCOV(Ag)-PN20
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details