Isolab, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 44
What Isolab, Inc. makes
Isolab, Inc. manufactures in vitro diagnostic tests and controls for hemoglobinopathies, neonatal chemistry, and infectious disease screening. Their portfolio includes hemoglobin electrophoresis controls, sickle cell and thalassemia assays, galactose metabolism tests, and chlamydia detection systems. The company also produces hemoglobin typing kits and quantitative hemoglobin controls for clinical and research use.
Isolab’s devices are regulated under FDA’s Class I and Class II categories, with many listed via the 510(k) pathway. Products are intended for use in the US, where compliance with FDA in vitro diagnostic device regulations applies. The company is based in the United States.
Catalogue
Search and filter all 44 devicesFrequently asked questions
How many devices does Isolab, Inc. have in the registry?
The registry currently lists 44 devices for Isolab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isolab, Inc.'s devices?
Among its 44 most recently registered devices, Isolab, Inc. has devices listed in FDA 510(k) (44 devices).
What risk classes do Isolab, Inc.'s devices fall under?
Among its 44 most recently registered devices, the classes recorded for Isolab, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isolab, Inc. in the registry?
The most recently registered devices listed for Isolab, Inc. include HDL-CHOLESTEROL CONTROL SERUM, RESOLVE-HB, SICKLE HB ASSAY and HEMOCARD(TM) CONTROL.