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Last updated

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AccuProbe Influenza B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141601
Basic UDI-DI
697334914HSB46K4
Reference
HSB46-100
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RapidFor™

VMD82

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684595030370
Basic UDI-DI
868459503VMD82SC49
Reference
VMD82SC
EMDN
W0105010801
EMDN description
MYCOPLASMA ANTIGEN DETECTION
First on market country
Germany
Authorised representative
-
Last updated
21.09.2026 21:33
Manufacturer productsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141335
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-20
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RapidFor™

-

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998277822
Basic UDI-DI
868459503VMD82SC49
Reference
VMD82SD
EMDN
W0105010801
EMDN description
MYCOPLASMA ANTIGEN DETECTION
First on market country
-
Authorised representative
-
Last updated
21.09.2026 21:33
Manufacturer productsView details
Allplex™ GI-Helminth(I) Assay

Allplex™ GI-Helminth(I) Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Seegene, Inc.
Manufacturer SRN
KR-MF-000022275
UDI-DI
08809240101919
Basic UDI-DI
924010GI10191CD
Reference
GI10191X
EMDN
W0105070504
EMDN description
GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141342
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-25
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RapidFor™

-

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998277839
Basic UDI-DI
868459503VMD82SC49
Reference
VMD82BC
EMDN
W0105010801
EMDN description
MYCOPLASMA ANTIGEN DETECTION
First on market country
-
Authorised representative
-
Last updated
21.09.2026 21:33
Manufacturer productsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141359
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-50
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141366
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-100
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Allplex™ GI-Helminth(I) Assay

Allplex™ GI-Helminth(I) Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Seegene, Inc.
Manufacturer SRN
KR-MF-000022275
UDI-DI
08809240101902
Basic UDI-DI
924010GI10191CD
Reference
GI10190Y
EMDN
W0105070504
EMDN description
GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141618
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-10
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141625
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-20
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Allplex™ GI-Helminth(I) Assay

Allplex™ GI-Helminth(I) Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Seegene, Inc.
Manufacturer SRN
KR-MF-000022275
UDI-DI
08809240101896
Basic UDI-DI
924010GI10191CD
Reference
GI10189Z
EMDN
W0105070504
EMDN description
GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
21.09.2026 21:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141632
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-25
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chocolate LAB-AGAR™ +PV

Chocolate LAB-AGAR™ +PV

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
BioMaxima Spółka Akcyjna
Manufacturer SRN
PL-MF-000039473
UDI-DI
05902643941045
Basic UDI-DI
59026439APCHPVMM
Reference
PW 3251
EMDN
W0104010206
EMDN description
MEDIA IN TUBES (SOLID & LIQUID)
First on market country
Poland
Authorised representative
-
Last updated
21.09.2026 21:32
Manufacturer productsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141649
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-50
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RapidFor™

VMD135SC

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684595034750
Basic UDI-DI
868459503VMD135SC9W
Reference
VMD135SC
EMDN
W0105090699
EMDN description
OTHER MULTIPLE PATHOGENS - RT & POC
First on market country
Germany
Authorised representative
-
Last updated
21.09.2026 21:32
Manufacturer productsView details
AccuProbe Influenza A/B Virus PCR Kit

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Hecin Scientific, Inc.
Manufacturer SRN
CN-MF-000019106
UDI-DI
06973349141656
Basic UDI-DI
697334914HSB49KA
Reference
HSB49-100
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
-
Authorised representative
Share info GmbH
Last updated
21.09.2026 21:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RapidFor™

-

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998279680
Basic UDI-DI
868459503VMD135SC9W
Reference
VMD135SD
EMDN
W0105090699
EMDN description
OTHER MULTIPLE PATHOGENS - RT & POC
First on market country
-
Authorised representative
-
Last updated
21.09.2026 21:32
Manufacturer productsView details