EUDAMED last updated this device on Jul 23, 2026

TRUPCR® Respiratory Pathogen Panel Kit

89080153043B287NZ

On the marketIVDR Class C

Applicable legislation: —
Organization name: 3B BlackBio Dx Limited
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 →: 08908015304279
Reference / catalog number: 3B288

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.

TRUPCR® Respiratory Pathogen Panel Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by 3B BlackBio Dx Limited. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: TRUPCR® Respiratory Pathogen Panel Kit
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 →: 08908015304279
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 →: 89080153043B287NZ
Reference / catalog number: 3B288
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: 1
Additional product description: The TRUPCR® Respiratory Pathogen Panel Kit is intended to identify and differentiate Staphylococcus aureus, Streptococcus pneumoniae, Klebsiella pneumoniae, Mycoplasma pneumoniae, Salmonella spp., Streptococcus pyogenes, Bordetella spp., Chlamydia pneumoniae, Streptococcus agalactiae, Acinetobacter baumannii, Pseudomonas aeruginosa, Legionella pneumophila, Haemophilus influenzae (A-F), Moraxella catarrhalis, Human Parechovirus, Human coronavirus (229E & NL63 alpha coronavirus and OC43 & HKU1 beta coronavirus), Human parainfluenza virus 1-4, Influenza A virus, Pandemic H1 influenza virus (pdm09), Influenza A (H3N2) virus, Influenza B virus, Influenza C virus, Enterovirus, Human metapneumoviruses (A/B), Human adenovirus, Human respiratory syncytial viruses (A/B), Human rhinovirus and Human bocavirus from respiratory specimens using Real time PCR. The results from the TRUPCR® Respiratory Pathogen Panel Kit must be interpreted within the context of all relevant clinical and laboratory findings.
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)08908015304279

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.

W0105900102REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market

TRUPCR® Respiratory Pathogen Panel Kit

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

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Manufacturer information

Certificates covering this device

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Certificates