Alpha-Tec Systems, Inc.
United StatesFDA applicant, unverified
Alpha-Tec Systems, Inc. is a medical device manufacturer, with 19 devices listed in FDA 510(k) (FDA Class I) as of 13 Nov 2026.
- Devices
- 19
Registry facts
- Registries
- FDA 510(k) 19
- Device classes
- FDA Class I 19
- Identifiers
- DUNS 103105524
What Alpha-Tec Systems, Inc. makes
Alpha-Tec Systems, Inc. manufactures in vitro diagnostic (IVD) devices for specimen processing and microscopy, including kits for liquefaction and decontamination of sputum, home-use faecal specimen collection, biological staining and controls, faecal parasite concentration, and single-use general microscopy slides.
All listed devices fall under Class I regulatory classification in the US. They are authorised via 510(k) premarket notifications and appear in the FDA’s Unapproved/Withdrawn Device List (UDI) registry.
Catalogue
Search and filter all 19 devicesCompany details
- DUNS number
- 103105524
Frequently asked questions
How many devices does Alpha-Tec Systems, Inc. have in the registry?
The registry currently lists 19 devices for Alpha-Tec Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alpha-Tec Systems, Inc.'s devices?
Among its 19 most recently registered devices, Alpha-Tec Systems, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Alpha-Tec Systems, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Alpha-Tec Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Alpha-Tec Systems, Inc. in the registry?
The most recently registered devices listed for Alpha-Tec Systems, Inc. include ATS PARASITOLOGY STAIN CONTROL SLIDE, PARA-PRO FC50, ATS TB RAPID STAIN SET PRODUCT #034-45 and ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION.