Genetic Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Genetic Laboratories, Inc. makes
Genetic Laboratories, Inc. manufactures pericardial patches designed to reinforce or repair the pericardium, including the PERIGUARD PERICARDIAL PATCH and PERI-GUARD PERICARDIAL PATCH, as well as suture strips for surgical applications. The company also produces BIOFLOW™, a device intended for vascular or fluid management in medical procedures.
The company’s products are regulated under Class I, Class II, and Class III device classifications in the US, with some authorised via FDA 510(k) and PMA pathways. These devices are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
Periguard Pericardial Patch Ref K821532
Regimes: 510(k) Registry: 510(k)Suture Strip Ref K842621
Regimes: 510(k) Registry: 510(k)Peri-Guard Pericardial Patch Ref K842066
Regimes: 510(k) Registry: 510(k)Bioflow(Tm) Ref P800064
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Genetic Laboratories, Inc. have in the registry?
The registry currently lists 4 devices for Genetic Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genetic Laboratories, Inc.'s devices?
Among its 4 most recently registered devices, Genetic Laboratories, Inc. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Genetic Laboratories, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Genetic Laboratories, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Genetic Laboratories, Inc. in the registry?
The most recently registered devices listed for Genetic Laboratories, Inc. include PERIGUARD PERICARDIAL PATCH, SUTURE STRIP, PERI-GUARD PERICARDIAL PATCH and BIOFLOW(TM).