Excel Scientific, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 8
What Excel Scientific, Inc. makes
Excel Scientific, Inc. manufactures lateral flow immunoassay devices for home use, including urine and serum pregnancy test kits, ovulation predictor test kits, and rapid antigen tests for Group A Streptococcus. Products range from single-use dipstick tests to modular test kits designed for point-of-care or home diagnostics.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance database. Products are intended for in vitro diagnostic use and comply with US regulatory requirements. The manufacturer is based in the United States.
Catalogue
Excel One Step Urine Hcg Pregnancy Dipstick Test Ref K970424
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Ez Sure Onestep Early Pregnancy Test Ref K962580
510(k) 510(k)Ez Sure Urine Dipstick Pregnancy Home Test Ref K970425
510(k) 510(k)- 510(k) 510(k)
Excel Onestep Urine Hcg Module Pregnancy Test Ref K963231
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Excel Scientific, Inc. have in the registry?
The registry currently lists 8 devices for Excel Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Excel Scientific, Inc.'s devices?
Among its 8 most recently registered devices, Excel Scientific, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Excel Scientific, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Excel Scientific, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Excel Scientific, Inc. in the registry?
The most recently registered devices listed for Excel Scientific, Inc. include EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST, ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT, EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST and EZ SURE ONESTEP EARLY PREGNANCY TEST.