LIAISON QuantiFERON-TB Gold Plus Assay
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software FDA PMA
- Generic Name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS FDA PMA
Identifiers
- PMA Number
- P180047 FDA PMA
- FDA Product Code
- NCD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The LIAISON QuantiFERON-TB Gold Plus Assay is an in vitro diagnostic test classified as a cell-mediated immunity test for Mycobacterium tuberculosis. It detects interferon-gamma (IFN-γ) in human lithium heparin plasma via chemiluminescence immunoassay (CLIA) using the LIAISON XL Analyzer, enabling qualitative assessment of Mycobacterium tuberculosis infection, including latent and active disease states. The assay employs QIAGEN QuantiFERON-TB Gold Plus Blood Collection Tubes containing peptide cocktails to stimulate whole blood samples, facilitating detection of antigen-specific immune responses.
The assay is performed exclusively on the LIAISON XL Analyzer and requires the use of QIAGEN QuantiFERON-TB Gold Plus Blood Collection Tubes. It is supplied as a single-use diagnostic kit, with results reported as positive, negative, or indeterminate via the optional LIAISON QuantiFERON Software. The LIAISON Control QuantiFERON-TB Gold Plus serves as a quality control sample, validated solely for use with the LIAISON XL Analyzer. Approved under FDA PMA (P180047), the device is intended for clinical use in conjunction with other diagnostic evaluations to aid patient management decisions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180047 | Class III | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P180047 24 fields · synced Sep 18, 2026