Clinical Controls, Inc.
United StatesFDA applicant, unverified
- Devices
- 18
What Clinical Controls, Inc. makes
Clinical Controls, Inc. manufactures liquid and urine controls for clinical laboratory testing, including assays for beta-2 microglobulin (B2M), C-reactive protein (CRP), fibrinogen, ammonia, albumin, glucose, ethanol, and cardiac markers such as CKMB and LD-1. Their products also cover linearity controls for whole blood glucose and immunoinhibition controls for cardiac enzymes. These controls are designed to support the validation and quality assurance of diagnostic testing processes.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed via the 510(k) pathway. Their controls are intended for use in laboratory settings and are registered with the FDA. The manufacturer is based in the United States.
Catalogue
Search and filter all 18 devicesFrequently asked questions
How many devices does Clinical Controls, Inc. have in the registry?
The registry currently lists 18 devices for Clinical Controls, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clinical Controls, Inc.'s devices?
Among its 18 most recently registered devices, Clinical Controls, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Clinical Controls, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Clinical Controls, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clinical Controls, Inc. in the registry?
The most recently registered devices listed for Clinical Controls, Inc. include LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2, LIQUISPEX URINE (MICRO)ALBUMIN CONTROL, PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 and CHEMSPEX(TM) AMMONIA CONTROL.