Pcl-Ria, Inc.
United StatesFDA applicant, unverified
- Devices
- 29
What Pcl-Ria, Inc. makes
Pcl-Ria, Inc. manufactures diagnostic reagents and standards for hormone assays, including human follicle-stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), and thyroxine (T4) products. Their portfolio also includes antibody-based diagnostic kits, such as rabbit antibody to digoxin and LH assay kits, as well as reference standards for thyroid and hormone testing.
These products are regulated under FDA Class I and Class II devices, with relevant submissions listed in the FDA’s 510(k) registry. The company operates in the United States, where its diagnostic reagents and standards are tracked for compliance with U.S. medical device regulations.
Catalogue
Search and filter all 29 devicesFrequently asked questions
How many devices does Pcl-Ria, Inc. have in the registry?
The registry currently lists 29 devices for Pcl-Ria, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pcl-Ria, Inc.'s devices?
Among its 29 most recently registered devices, Pcl-Ria, Inc. has devices listed in FDA 510(k) (29 devices).
What risk classes do Pcl-Ria, Inc.'s devices fall under?
Among its 29 most recently registered devices, the classes recorded for Pcl-Ria, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pcl-Ria, Inc. in the registry?
The most recently registered devices listed for Pcl-Ria, Inc. include HUMAN FOLLICLE STIMULATING HORMONE, LUTEINIZING HORMONE, B-GCG SYSTEM BY RIA and THYROID STIMULATING HORMONE.