Sealite Sciences, Inc.
United StatesFDA applicant, unverified
- Devices
- 11
What Sealite Sciences, Inc. makes
Sealite Sciences, Inc. manufactures diagnostic assay kits for hormone and biomarker testing, including intact parathyroid hormone (PTH), luteinizing hormone (LH), prolactin, follicle-stimulating hormone (FSH), thyroid-stimulating hormone (TSH), ferritin, and human growth hormone. These products are designed for laboratory use to measure specific hormone levels in patient samples, supporting endocrine and metabolic diagnostics.
The company’s assay kits are regulated under FDA’s Class I and Class II device classifications, with some products requiring 510(k) clearance. These assays are listed in the FDA’s 510(k) database, indicating their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Sealite Sciences, Inc. have in the registry?
The registry currently lists 11 devices for Sealite Sciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sealite Sciences, Inc.'s devices?
Among its 11 most recently registered devices, Sealite Sciences, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do Sealite Sciences, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Sealite Sciences, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sealite Sciences, Inc. in the registry?
The most recently registered devices listed for Sealite Sciences, Inc. include SEALITE SCIENCES INC., SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY, AQUALITE INTACT PTH and SEALITE SCIENCES, INC. AQUALITE LH.