Precision Biologic
CanadaFDA applicant, unverified FDA
Precision Biologic is a medical device manufacturer, with 68 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 68
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 58
- FDA 510(k) 10
- Device classes
- FDA Class II 61
- FDA Class I 7
At a glance
Market reach
- United States
- FDA establishment
What Precision Biologic makes
Precision Biologic manufactures in vitro diagnostic (IVD) reagents, controls, and clotting kits for coagulation testing, including multiple coagulation factor assays, lupus anticoagulant markers, prothrombin time (PT), and activated partial thromboplastin time (APTT). Their products are designed for laboratory use to measure coagulation factors such as Factor VIII, Factor IX, and Factor XII, as well as to detect lupus anticoagulant activity. Examples include chromogenic reagents, deficient plasma controls, and specialized clotting kits for diagnostic evaluation.
The company’s portfolio includes devices classified as Class I and Class II under regulatory frameworks, with products listed via FDA pathways such as the 510(k) and UDI requirements. These diagnostics are intended for use in clinical laboratories to support diagnostic decision-making for coagulation disorders. The manufacturer operates from the United States.
Catalogue
Search and filter all 68 devicesShowing 1-50 of 68
FDA establishments
- Precision Biologic Inc CA
Frequently asked questions
How many devices does Precision Biologic have in the registry?
The registry currently lists 68 devices for Precision Biologic. Devices recorded under merged duplicate company entries are counted once.
Which registries list Precision Biologic's devices?
Among its 50 most recently registered devices, Precision Biologic has devices listed in FDA GUDID (50 devices).
What risk classes do Precision Biologic's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Precision Biologic's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Precision Biologic in the registry?
The most recently registered devices listed for Precision Biologic include CRYOcheck Factor VIII Chromogenic CCCF08, CRYOcheck Chromogenic Factor IX CCCF09, CRYOcheck™ Factor IX Deficient Plasma FDP09-10 and CRYOcheck™ LA Sure™ SUR-10.
Which FDA establishments are linked to Precision Biologic?
1 FDA establishment is linked to Precision Biologic in the registry; they are listed on the company page.