Biotecx Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 15
What Biotecx Laboratories, Inc. makes
Biotecx Laboratories, Inc. manufactures diagnostic assay kits for hormone and thyroid marker testing, including enzyme immunoassay (EIA) and radioimmunoassay (RIA) formats for cortisol, progesterone, estradiol, aldosterone, thyroxine (T3/T4), and thyroid-binding globulin (TBG). The company also produces an electroplethysmograph, a device used for measuring blood flow and vascular activity in peripheral tissues.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Biotecx Laboratories, Inc. have in the registry?
The registry currently lists 15 devices for Biotecx Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotecx Laboratories, Inc.'s devices?
Among its 15 most recently registered devices, Biotecx Laboratories, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Biotecx Laboratories, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Biotecx Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotecx Laboratories, Inc. in the registry?
The most recently registered devices listed for Biotecx Laboratories, Inc. include CORTISOL CLASP-BEAD EIA KIT, PROGESTERONE DIRECT RIA KIT-RADIOIMM, TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE and ESTRADIOL DIRECT RIA KIT.