Product code NCD
- Device name
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P180047S039 | LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II | DiaSorin, Inc. | 2026-01-26 |
| P010033S052 | QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test | Qiagen | 2026-01-23 |
| P180047S041 | LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2025-12-19 |
| P010033S051 | QuantiFERON-TB Gold Plus Test | Qiagen | 2025-11-21 |
| P180047S037 | LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2025-10-10 |
| P180047S040 | LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON-TBGold Plus | DiaSorin, Inc. | 2025-08-28 |
| P180047S038 | LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2025-08-21 |
| P180047S035 | LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus | DiaSorin, Inc. | 2025-06-04 |
| P180047S032 | LIAISON QuantiFERON - TB Gold Plus, LIAISON XL Control QuantiFERON - TB Gold Plus | DiaSorin, Inc. | 2025-04-25 |
| P180047S034 | LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software | DiaSorin, Inc. | 2025-04-10 |
| P180047S033 | LIAISON QuantiFERON-TB Gold Plus; LIAISON Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2025-02-25 |
| P180047S031 | LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2025-01-06 |
| P180047S030 | LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2024-12-13 |
| P180047S028 | LIAISON QuantiFERON-TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2024-10-11 |
| P180047S027 | LIAISON® QuantiFERON®-TB Gold Plus, LIAISON® Control QuantiFERON®-TB Gold Plus | DiaSorin, Inc. | 2024-09-05 |
| P180047S026 | LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2024-07-12 |
| P180047S025 | LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2024-06-04 |
| P010033S050 | QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test | Qiagen | 2024-02-09 |
| P010033S049 | QuantiFERON®-TB Gold Plus Test | Qiagen | 2023-12-15 |
| P180047S024 | LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2023-11-08 |
| P180047S023 | LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2023-09-28 |
| P180047S019 | LIAISON QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2023-07-18 |
| P180047S021 | LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software | DiaSorin, Inc. | 2023-02-01 |
| P010033S048 | QUANTIFERON®-TB Gold Plus Test | Qiagen | 2023-01-24 |
| P180047S020 | LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software | DiaSorin, Inc. | 2022-12-21 |
| P180047S022 | LIAISON® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus | DiaSorin, Inc. | 2022-12-08 |
| P180047S018 | LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus | DiaSorin, Inc. | 2022-08-11 |
| P180047S017 | LIAISON® QuantiFERON TB-Gold Plus assay and Control | DiaSorin, Inc. | 2022-07-08 |
| P180047S016 | LIAISON® QuantiFERON TB-Gold Plus assay and Control | DiaSorin, Inc. | 2022-06-23 |
| P180047S015 | LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus | DiaSorin, Inc. | 2022-05-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 18056771104415 | LIAISON QuantiFERON TB Gold Plus II | Diasorin Inc. | 2026-02-20 |
| 08056771104470 | LIAISON Control QuantiFERON TB Gold Plus II | Diasorin Inc. | 2026-02-20 |
| 08056771104418 | LIAISON QuantiFERON TB Gold Plus II | Diasorin Inc. | 2026-02-20 |
| 08056771104401 | LIAISON QuantiFERON TB Gold Plus II | Diasorin Inc. | 2026-02-19 |
| 08056771104098 | LIAISON QUANTIferon TB Gold Plus | DIASORIN SPA | 2023-12-14 |
| 08056771104081 | LIAISON QUANTIferon TB Gold Plus | DIASORIN SPA | 2023-09-08 |
| 08056771602945 | LIAISON QUANTIferon TB Gold Plus | Diasorin Inc. | 2023-09-08 |
| 08056771602952 | LIAISON Control QUANTIferon TB Gold Plus | Diasorin Inc. | 2023-09-08 |
| 08056771603300 | LIAISON QUANTIferon TB Gold Plus | Diasorin Inc. | 2023-07-21 |
| 14053228033568 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2019-12-18 |
| 14053228033575 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2019-12-18 |
| 08056771103572 | LIAISON® QuantiFERON® Software | DIASORIN SPA | 2019-12-09 |
| 08056771103275 | LIAISON® Control QuantiFERON®-TB Gold Plus | DIASORIN SPA | 2019-12-09 |
| 08056771103268 | LIAISON Quantiferon TB Gold Plus | DIASORIN SPA | 2019-12-09 |
| 14053228015885 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2017-10-02 |
| 14053228015892 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2017-10-02 |
| 14053228015908 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2017-10-02 |
| 14053228015915 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2017-10-02 |
| 04053228015864 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2017-10-02 |
| 04053228015871 | QuantiFERON®-TB Gold Plus | QIAGEN SCIENCES INC. | 2017-10-02 |
| 14053228002120 | QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack | QIAGEN SCIENCES INC. | 2017-01-04 |
| 14053228002137 | QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude | QIAGEN SCIENCES INC. | 2017-01-04 |
| 14053228002144 | QuantiFERON-TB Gold Blood Collection Tubes | QIAGEN SCIENCES INC. | 2017-01-04 |
| 14053228002151 | QuantiFERON-TB Gold Blood Collection Tubes - High Altitude | QIAGEN SCIENCES INC. | 2017-01-04 |
| 04053228002109 | QuantiFERON-TB Gold 2 Plate Kit | QIAGEN SCIENCES INC. | 2017-01-04 |
| 04053228002116 | QuantiFERON-TB Gold Reference Lab Pack | QIAGEN SCIENCES INC. | 2017-01-04 |