Product code LOK
- Device name
- Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- IM
- 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 |
|---|---|---|---|
| P930036S026 | ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| P120008S032 | ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) | Abbott Laboratories | 2026-05-11 |
| P010007S025 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| P120008S031 | ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) | Abbott Laboratories | 2026-02-12 |
| P980041S051 | Access AFP (on DxI 9000 Analyzer) | Beckman Coulter, Inc. | 2025-11-03 |
| P010007S024 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| P930036S025 | ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |
| P010007S023 | IMMULITE 2000 Alpha-Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | 2025-04-11 |
| P120008S030 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | 2025-04-03 |
| P930036S024 | Atellica IM Alpha Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | 2024-09-23 |
| P120008S029 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | 2024-03-22 |
| P930036S021 | Atellica IM Alpha Fetoprotein (AFP) | Siemens Healthcare Diagnostics, Inc. | 2024-02-08 |
| P120008S028 | Architect AFP and Alinity i AFP | Abbott Laboratories | 2024-01-30 |
| P930036S022 | ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA | Siemens Healthcare Diagnostics, Inc. | 2023-12-18 |
| P120008S027 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | 2023-12-14 |
| P120008S026 | Alinity i AFP Reagent Kit | Abbott Laboratories | 2023-11-08 |
| P120008S022 | ARCHITECT AFP, Alinity i AFP | Abbott Laboratories | 2023-10-11 |
| P120008S025 | Alinity i AFP | Abbott Laboratories | 2023-09-25 |
| P010007S016 | IMMULITE® AFP, IMMULITE® 2000 AFP | Siemens Healthcare Diagnostics, Inc. | 2023-08-30 |
| P120008S024 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | 2023-07-10 |
| P120008S023 | ARCHITECT AFP, Alinity i AFP | Abbott Laboratories | 2023-06-22 |
| P120008S021 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | 2023-01-30 |
| P980041S050 | Access AFP Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2022-12-16 |
| P010007S017 | IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 AFP | Siemens Healthcare Diagnostics, Inc. | 2022-10-14 |
| P120008S020 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | 2022-10-12 |
| P930036S020 | ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP | Siemens Healthcare Diagnostics, Inc. | 2022-09-30 |
| P930036S019 | Atellica® IM Alpha Fetoprotein (AFP) Assay | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| P010007S015 | IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | 2022-03-29 |
| P120008S019 | ARCHITECT AFP / Alinity i AFP | Abbott Laboratories | 2021-12-17 |
| P120008S018 | ARCHITECT AFP (LN 3P36) | Abbott Laboratories | 2021-12-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590744403 | Access AFP | Beckman Coulter, Inc. | 2025-11-10 |
| 00630414293561 | Atellica IM Calibrator D | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294117 | Atellica IM Calibrator D | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00380740130794 | Alinity | Abbott Ireland Diagnostics | 2019-11-06 |
| 00380740130800 | Alinity | Abbott Ireland Diagnostics | 2019-11-06 |
| 00380740130817 | Alinity | Abbott Ireland Diagnostics | 2019-11-06 |
| 00380740130824 | Alinity | Abbott Ireland Diagnostics | 2019-11-06 |
| 00630414597720 | Atellica IM AFP MCM | Siemens Healthcare Diagnostics Inc. | 2018-11-14 |
| 00630414238807 | Atellica IM AFP | Siemens Healthcare Diagnostics Inc. | 2018-11-14 |
| 00630414238791 | Atellica IM AFP | Siemens Healthcare Diagnostics Inc. | 2018-11-14 |
| 00630414598376 | Atellica IM Calibrator D | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 00630414598369 | Atellica IM Calibrator D | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 00630414022963 | ADVIA Centaur® AFP | Siemens Healthcare Diagnostics Inc. | 2016-07-12 |
| 00380740081317 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740081294 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00380740081287 | ARCHITECT | Abbott Ireland Diagnostics | 2014-11-18 |
| 00630414126319 | ADVIA Centaur® Systems, ACS 180® Systems AFP MCM | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414177328 | ADVIA Centaur® AFP | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414177335 | ADVIA Centaur® AFP | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414124940 | ADVIA Centaur® Systems, ACS:180® Systems Calibrator D | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414124933 | ADVIA Centaur® Systems, ACS:180® Systems Calibrator D | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414124797 | ADVIA Centaur® Calibrator D | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 06438147321322 | AutoDELFIA hAFP kit | Wallac Oy | 2014-09-24 |
| 00630414953519 | IMMULITE®/IMMULITE®1000 Systems AF AFP Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2014-09-24 |
| 00630414961033 | IMMULITE® 2000 Systems AF AFP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2014-09-24 |
| 00630414961040 | IMMULITE® 2000 Systems AF AFP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2014-09-24 |
| 00630414963594 | IMMULITE®/IMMULITE®1000 Systems AF AFP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2014-09-24 |
| 06438147321315 | AutoDELFIA hAFP Kit | Wallac Oy | 2014-09-24 |
| H628332161 | Access AFP Sample Diluent | Beckman Coulter, Inc. | 2014-09-16 |
| H628332111 | Access AFP | Beckman Coulter, Inc. | 2014-09-16 |