Product code LKV
- Device name
- Enzyme Immunoassay, Fetal Fibronectin
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CH
- 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 |
|---|---|---|---|
| P920048S029 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2026-03-05 |
| P920048S028 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2026-03-05 |
| P920048S027 | Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System | Hologic, Inc. | 2024-12-06 |
| P920048S026 | TLiIQ QCette | Hologic, Inc. | 2024-10-23 |
| P920048S025 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2023-12-21 |
| P920048S024 | Rapid fFN for the TLilQ System | Hologic, Inc. | 2023-08-24 |
| P920048S023 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2022-05-09 |
| P920048S022 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2022-04-13 |
| P920048S021 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2022-02-28 |
| P920048S019 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2021-05-21 |
| P920048S020 | Rapid fFN for the TLilQ System | Hologic, Inc. | 2021-04-29 |
| P920048S015 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2020-11-06 |
| P920048S018 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2020-10-02 |
| P920048S016 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2020-09-03 |
| P920048S017 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2020-08-12 |
| P920048S013 | Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay | Hologic, Inc. | 2020-01-28 |
| P920048S014 | Rapid fFN for the TLiIQ System | Hologic, Inc. | 2018-12-17 |
| P920048S011 | RAPID FFN FOR THE TLIIQ SYSTEM | Hologic, Inc. | 2016-02-05 |
| P920048S009 | RAPID FFN FOR THE TLIIQ SYSTEM | Hologic, Inc. | 2015-06-24 |
| P920048S008 | RAPID FFN CONTROL KIT | Hologic, Inc. | 2014-07-24 |
| P920048S006 | RAPID FFN FOR THE TLIIQ SYSTEM | Hologic, Inc. | 2008-10-22 |
| P920048S005 | FULLTERM FETAL FIBRONECTIN TEST | Hologic, Inc. | 2008-01-29 |
| P920048S003 | RAPID FFN FOR THE TLI SYSTEM | Hologic, Inc. | 2001-03-09 |
| P920048S002 | ADEZA FETAL FIBRONECTIN EIK | Hologic, Inc. | 1998-08-14 |
| P920048S001 | ADEZA FETAL FIBRONECTIN EIK | Hologic, Inc. | 1997-01-08 |
| P920048 | FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK) | Hologic, Inc. | 1995-09-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 25420045500874 | TLiIQ System | Hologic, Inc. | 2024-08-07 |
| 15420045505346 | FETAL FIBRONECTIN ENZYME IMMUNOASSAY | Hologic, Inc. | 2017-02-08 |
| 15420045501171 | TLI IQ® | Hologic, Inc. | 2014-09-30 |
| 15420045500877 | TLiIQ System | Hologic, Inc. | 2014-09-02 |
| 15420045500884 | TLiIQ System | Hologic, Inc. | 2014-09-02 |
| 25420045501154 | Rapid fFN® | Hologic, Inc. | 2014-08-18 |
| 15420045501164 | Rapid fFN® | Hologic, Inc. | 2014-08-18 |