EUDAMED last updated this device on Aug 14, 2026

ChainFor™

B-08683548257925

On the marketIVDD — General

Applicable legislation: —
Organization name: Vitrosens Biotechnology Inc.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08683548257925
Reference / catalog number: PCR66

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

ChainFor™ is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Vitrosens Biotechnology Inc.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ChainFor™
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08683548257925
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-08683548257925
Reference / catalog number: PCR66
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The Dengue qPCR Kit is an in vitro diagnostic real-time PCR assay intended for the manual qualitative detection of Dengue virus nucleic acids in human EDTA plasma sample. The assay is intended for professional use only and is designed to aid the diagnosis of Dengue virus infection which is causing Dengue fever, severe dengue and dengue hemorrhagic fever.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08683548257925

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105040611DENGUE VIRUS

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

Caution
Consult instructions for use
Do not use if package is damaged
Do not use past indicated date

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Türkiye; available across 1 country total.

Country	On market since	Until
TürkiyePrimary placement	—	Still on market

ChainFor™

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UDI-DI DataMatrix

EMDN nomenclature code(s)

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Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

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Safety

Regulatory

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Certificates

Certificates covering this device

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Certificates

Certificates covering this device

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