Product code MVD
- Device name
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P980024S022 | PathVysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. | 2022-03-18 |
| P980024S021 | PathVysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. | 2020-12-11 |
| P980024S020 | PathVysion HER-2 DA Probe Kit | Abbott Molecular, Inc. | 2019-05-08 |
| P980024S019 | PathVysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. | 2018-08-29 |
| P980024S018 | Path Vysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. | 2018-07-11 |
| P980024S017 | Path Vysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. | 2018-03-12 |
| P980024S016 | Path Vysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. | 2017-12-06 |
| P040005S014 | HER2 IQFISH pharmDx | Agilent Technologies Singapore (International) Pte , Ltd. | 2017-04-12 |
| P980024S015 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2016-09-29 |
| P980024S014 | PATH VYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2016-07-13 |
| P040005S013 | DAKOCYTOMATION HER2 FISH PHARMDX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | 2016-04-12 |
| P040005S012 | HER2 IQFISH PHARMDX | Agilent Technologies Singapore (International) Pte , Ltd. | 2016-01-29 |
| P040005S011 | HER2 IQFISH PHARMDX | Agilent Technologies Singapore (International) Pte , Ltd. | 2015-09-10 |
| P980024S013 | PATH VYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2014-07-16 |
| P980024S012 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2013-12-20 |
| P980024S011 | THE PATH VYSION HER-2 DNA PRODE KIT | Abbott Molecular, Inc. | 2013-11-27 |
| P040005S010 | HER2 IQFISH PHARMDX | Agilent Technologies Singapore (International) Pte , Ltd. | 2013-08-28 |
| P040005S009 | HER2 FISH PHARMADX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | 2013-02-22 |
| P980024S010 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2013-02-10 |
| P980024S009 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2012-12-26 |
| P980024S007 | PATH VYSION HER-2 DNA PROBE KIT ASSAY | Abbott Molecular, Inc. | 2012-12-20 |
| P040005S007 | HER2 IQFISH PHARMDX | Agilent Technologies Singapore (International) Pte , Ltd. | 2012-12-05 |
| P040005S008 | HER2 FISH PHARMDX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | 2012-07-31 |
| P980024S008 | PATH VYSION HER-2 DNA PROBE KIT ASSAY | Abbott Molecular, Inc. | 2012-07-17 |
| P040005S006 | HER2 FISH PHARMADX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | 2012-06-08 |
| P980024S006 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2012-02-27 |
| P980024S005 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2011-04-18 |
| P980024S004 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 2011-01-10 |
| P040005S005 | HER2 FISH PHARMDX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-10-20 |
| P040005S004 | HER2 FISH PHARMDX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-06-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884999001732 | PathVysion | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999001756 | PathVysion | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999001763 | PathVysion | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 05700572032465 | HER2 IQFISH pharmDx™ | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2014-09-15 |