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111 device results listed.

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Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804504
Basic UDI-DI: B-06936155804504
Reference: ITP71004-TC20
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804498
Basic UDI-DI: B-06936155804498
Reference: ITP71004-TC10
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804481
Basic UDI-DI: B-06936155804481
Reference: ITP71004-TC1
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Dengue NS1 Ag Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804474
Basic UDI-DI: B-06936155804474
Reference: ITP71003-TC40
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

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ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804467
Basic UDI-DI: B-06936155804467
Reference: ITP71002
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid FOB Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804443
Basic UDI-DI: B-06936155804443
Reference: ITP13001-DS50
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Malaria(p.f/p.v) Tri-line Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804382
Basic UDI-DI: B-06936155804382
Reference: ITP11003-TC25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Malaria(p.f.) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804375
Basic UDI-DI: B-06936155804375
Reference: ITP11002-TC40
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804351

IVD Annex II List ANot specifiedOn the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804351
Basic UDI-DI: B-06936155804351
Reference: ITP02153-TC40
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804344

IVD Annex II List ANot specifiedOn the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804344
Basic UDI-DI: B-06936155804344
Reference: ITP02153-TC10
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Portugal
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804337

IVD Annex II List ANot specifiedNo longer on the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804337
Basic UDI-DI: B-06936155804337
Reference: ITP02152-TC40
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804320

IVD Annex II List ANot specifiedNo longer on the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804320
Basic UDI-DI: B-06936155804320
Reference: ITP02152-TC25
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804313

IVD Annex II List ANot specifiedNo longer on the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804313
Basic UDI-DI: B-06936155804313
Reference: ITP01153-TC40
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804306

IVD Annex II List ANot specifiedOn the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804306
Basic UDI-DI: B-06936155804306
Reference: ITP01153-TC10
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804290

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804290
Basic UDI-DI: B-06936155804290
Reference: ITP01152-TC40
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

06936155804283

IVD Annex II List ANot specifiedNo longer on the marketSingle useSterile

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804283
Basic UDI-DI: B-06936155804283
Reference: ITP01152-TC25
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Tricyclic Antidepressants (TCA) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803958
Basic UDI-DI: B-06936155803958
Reference: ITP06011-TC40
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Methamphetamine (MET) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803934
Basic UDI-DI: B-06936155803934
Reference: ITP06005-TC40
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Methadone (MTD) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803927
Basic UDI-DI: B-06936155803927
Reference: ITP06008-TC40
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Ketamine (KAN) Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803910
Basic UDI-DI: B-06936155803910
Reference: ITP06012-TC40
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:12

Manufacturer products Authorised representative products Authorised representative actors View details