Bio-Analytics Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 19
What Bio-Analytics Laboratories, Inc. makes
Bio-Analytics Laboratories, Inc. manufactures diagnostic reagent kits for clinical chemistry testing, including enzymatic and kinetic assays for urea nitrogen, uric acid, acetaminophen, LDH-L, alpha-amylase, albumin, iron, magnesium, and erythrocyte measurements. Their portfolio also includes colorimetric and operational check kits for laboratory use.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These reagents are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Bio-Analytics Laboratories, Inc. have in the registry?
The registry currently lists 19 devices for Bio-Analytics Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Analytics Laboratories, Inc.'s devices?
Among its 19 most recently registered devices, Bio-Analytics Laboratories, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Bio-Analytics Laboratories, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Bio-Analytics 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 Bio-Analytics Laboratories, Inc. in the registry?
The most recently registered devices listed for Bio-Analytics Laboratories, Inc. include UREA NITROGEN, KINETIC, URIC ACID (TPTZ) COLORINMETRIC, ACETAMINOPHEN(PARACETAMOL and LDH-L LIQUID ENZYMATIC, KINETIC KIT.