Precision Biologicals, Inc.
CanadaFDA applicant, unverified
- Devices
- 20
What Precision Biologicals, Inc. makes
Precision Biologicals, Inc. manufactures diagnostic reagents and controls for coagulation testing, including fecal collection kits for clinical specimen handling and plasma-based controls for in-vitro coagulation assays. These products include factor-deficient plasmas (e.g., Factor V, IX, XI, XII), reference plasmas, lupus plasmas, and APTT reagents. The company also supplies platelet lysate and INR validation sets for laboratory quality assurance.
The portfolio comprises Class I and Class II devices, regulated under the FDA’s 510(k) clearance pathway. Products are listed in the FDA’s 510(k) database, with specific devices authorised for in-vitro diagnostic use. The company operates from the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Precision Biologicals, Inc. have in the registry?
The registry currently lists 20 devices for Precision Biologicals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Precision Biologicals, Inc.'s devices?
Among its 20 most recently registered devices, Precision Biologicals, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Precision Biologicals, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Precision Biologicals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Precision Biologicals, Inc. in the registry?
The most recently registered devices listed for Precision Biologicals, Inc. include SAF FECAL COLLECTION KIT, CRYO CHECK FACTOR V DEFICIENT PLASMA, CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) and CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML).