Product catalogue

IVD products for qualified sourcing.

A practical starting point for qualified distributors and laboratories. Each product family below explains typical use, the information needed to select a model, and the documents that can be requested for review.

Send your requirements ↗

03RESPIRATORY &
INFECTIOUS TESTING

Professional testing solutions

Respiratory & infectious disease testing

Compatible assay, control and consumable workflows for instrument-led infectious-disease projects. The exact targets, specimen types, instrument compatibility and local intended use must be confirmed after the proposed instrument workflow is selected.

Reference performance — confirm against final assay IFU

As fast as30 minInfluenza A/B PCR result

Analytical sensitivity1,000copies/mL for the referenced influenza A/B assay

Assay format1 tubesimultaneous influenza A/B differentiation

Priority product scope

Six respiratory-virus panel testing projects
Influenza A/B and respiratory syncytial virus testing
Mycoplasma pneumoniae and Bordetella pertussis testing
Norovirus and hepatitis B testing
Selected antimicrobial-resistance marker testing
Related extraction reagents, controls and consumables

Typical applications

Hospital, reference-laboratory and qualified distributor projects
Respiratory-season readiness and infectious-disease workflows
Fever-clinic and respiratory-clinic professional laboratory support
Professional laboratory use under the product’s approved intended use

Key product configuration

Target panel: respiratory viruses, influenza A/B, mycoplasma, pertussis, norovirus, hepatitis B or resistance markers
Specimen type: confirm the specimen types stated in the exact assay instructions for use
Workflow: confirm compatible extraction reagents, PCR platform and control materials
Capacity: confirm tests per run, daily throughput and reporting turnaround for the proposed product
Storage and transport: confirm required temperatures, shelf life and cold-chain conditions by exact product

Documents to request

Model-specific data sheet, assay instructions for use and user manual
Compatible instrument, extraction and consumables list
Sample storage, transport and shelf-life information
Available test, quality and manufacturer documentation
Available market documentation for buyer and local adviser review

Request infectious-disease product review ↗

01MOLECULAR
INSTRUMENTS

Instruments, extraction & automation

Molecular diagnostic instruments

Our primary offer for laboratories seeking molecular platforms, nucleic-acid extraction and workflow automation. Instrument selection is based on throughput, site conditions and destination-market requirements; compatible assays and consumables are then scoped to the confirmed workflow.

Reference performance — confirm against final instrument specification

High-throughput line624samples / 8 h

24-hour capacity2,160samples / 24 h

Compact PCR workflow35 minas fast as per run; up to 64 targets

Unattended operation192tests per operation; up to 6 items on board

Priority product scope

Real-time PCR and selected molecular diagnostic platforms
Nucleic-acid extraction instruments
Automated or semi-automated extraction workstations
Liquid-handling or sample-preparation workflow accessories
Plates, tubes, tips and compatible workflow consumables

Typical applications

Professional molecular-diagnostics laboratories
Hospital and reference-laboratory workflow build-outs
Distributor projects that include installation and service planning
Laboratories upgrading manual extraction to an automated workflow
Projects requiring stable recurring consumables supply

Key product configuration

Amplification format: real-time PCR or other manufacturer-defined molecular workflow
Instrument capacity: confirm channels, samples per run, throughput and run time by exact model
Extraction capacity: confirm supported sample types, extraction volume and automation level
Workflow interface: confirm barcode handling, LIS connectivity and compatible consumables where required
Site requirements: confirm voltage, installation space, environmental limits and service plan by exact model

Documents to request

Exact-model specification, user manual and compatible consumables list
Throughput, run-time and sample-capacity information
Installation, power, environmental and maintenance requirements
Packing dimensions, net weight and transport requirements
Available manufacturer quality and market documentation for buyer review

Request molecular-instrument review ↗

02HBA1C &
IMMUNOASSAY

Chronic care & specialised clinical testing

HbA1c & clinical immunoassay

For buyers planning HbA1c or chemiluminescence analyser projects. The analyser system and local service plan are confirmed first; reagent menus, controls and recurring consumables are then matched to the chosen platform and destination market.

Reference performance — confirm against final analyser and assay specification

HbA1c analysis60 secper sample on the referenced high-throughput configuration

Continuous loading110sample positions on the referenced HbA1c configuration

AD assay platform200 T/Htesting throughput; first report in 20 min

HbA1c precisionCV ≤ 1%as stated for the referenced high-throughput configuration

Priority product scope

HbA1c analysers and compatible reagents, controls and calibrators
Chemiluminescence immunoassay analysers and consumables
Cardiovascular-marker testing projects
Inflammation-marker testing projects
Alzheimer’s disease testing projects, subject to exact assay and market review
Reagent, calibration and quality-control supply planning

Typical applications

Hospital and independent clinical laboratories
Chronic-care and diabetes-management programmes
Emergency and routine laboratory workflows, subject to proposed assay scope
Distributor analyser-and-reagent projects with local service planning
Laboratories requiring predictable reagent replenishment

Key product configuration

HbA1c method and reportable range: confirm against the exact analyser documentation
Immunoassay menu: confirm available cardiovascular, inflammation and other specialty assays by exact model
Capacity: confirm tests per hour, sample loading and daily throughput for the proposed system
Reagent conditions: confirm pack format, storage temperature, onboard stability and shelf life
System requirements: confirm voltage, installation, maintenance schedule and local service coverage

Documents to request

Data sheet, intended-use statement and instructions for use
Assay menu, compatible reagents, controls and calibrators list
Consumables schedule, storage conditions and shelf-life information
Installation, maintenance and operator-training requirements
Available quality, traceability and market documentation

Request HbA1c & immunoassay review ↗

Compliance boundary

The contracting manufacturer or exporter provides product documentation. The buyer confirms destination-market access.

Before purchase, the buyer should confirm with its local regulatory adviser, importer of record and customs broker whether the exact product may be imported, registered, distributed and used as intended in the destination. A product category, CE marking, test report or manufacturer document does not by itself confirm local market access.

Start a product review ↗