Amnisure International, LLC
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Amnisure International, LLC makes
Amnisure International, LLC manufactures the AMNISURE Fetal Membranes Rupture Test (Model FMRT-1), a diagnostic device designed to detect the presence of amniotic fluid in vaginal secretions, aiding in the assessment of fetal membrane integrity during pregnancy.
The device is classified as Class I under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Amnisure International, LLC, initiated on 2007-10-03. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 3 Oct 2007 Z-0120-2008 Unclassified (pre-2012) Terminated Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
Full distribution text
- 3 Oct 2007 Z-0120-2008 Unclassified (pre-2012) Terminated Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
Frequently asked questions
How many devices does Amnisure International, LLC have in the registry?
The registry currently lists 1 device for Amnisure International, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amnisure International, LLC's devices?
Among its 1 most recently registered device, Amnisure International, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Amnisure International, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Amnisure International, LLC's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Amnisure International, LLC?
FDA recall records list 1 recall initiated by Amnisure International, LLC, the most recent initiated on 3 Oct 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Amnisure International, LLC in the registry?
The most recently registered devices listed for Amnisure International, LLC include AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1.