EUDAMED last updated this device on Jul 2, 2026

ichroma™ IGRA-TB for 8

880613300138BZ

On the marketIVDR Class C

Applicable legislation: —
Organization name: Boditech Med 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 →: 08806133048986
Reference / catalog number: CFPC-86-2

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.

ichroma™ IGRA-TB for 8 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Boditech Med Inc.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ichroma™ IGRA-TB for 8
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 →: 08806133048986
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 →: 880613300138BZ
Reference / catalog number: CFPC-86-2
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: IVDR Class C
Applicable legislation: —
Status: On the market

Device details

Quantity: 24
Additional product description: ichroma™ IGRA-TB for 8 is an automated fluorescence immunoassay (FIA) for qualitative determination of IFN-γ (interferon-gamma) released in response to in vitro stimulation by Mycobacterium tuberculosis specific antigen in human whole blood.
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)08806133048986

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

W0105010799MYCOBACTERIA REAGENTS - OTHER

Critical warnings

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

Consult instructions for use
Do not re-use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Slovakia; available across 32 countries total.

Country	On market since	Until
SlovakiaPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

Related searches

IVDR Class C medical devices in EUDAMED

Device identification

Trade name: ichroma™ IGRA-TB for 8
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 →: 08806133048986
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 →: 880613300138BZ
Reference / catalog number: CFPC-86-2
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

Device details

Quantity: 24
Additional product description: ichroma™ IGRA-TB for 8 is an automated fluorescence immunoassay (FIA) for qualitative determination of IFN-γ (interferon-gamma) released in response to in vitro stimulation by Mycobacterium tuberculosis specific antigen in human whole blood.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Slovakia; available across 32 countries total.

Country	On market since	Until
SlovakiaPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

ichroma™ IGRA-TB for 8

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

Related devices