Hichem Diagnostics
Country not established
- Devices
- 41
What Hichem Diagnostics makes
Hichem Diagnostics manufactures in vitro diagnostic reagents and linearity standards for clinical chemistry testing, including uric acid, triglycerides, calcium, creatinine, protein, lipids, urea, glucose, iron, magnesium, and lactate dehydrogenase (LDH/L) assays. Their products also cover calibrators and serum range linearity standards for multi-constituent testing.
The company’s portfolio includes Class I and Class II in vitro diagnostic devices, all of which are subject to FDA 510(k) clearance requirements. These products are listed under the FDA’s regulatory framework and are intended for use in laboratory settings for biochemical analysis.
Catalogue
Search and filter all 41 devicesFrequently asked questions
How many devices does Hichem Diagnostics have in the registry?
The registry currently lists 41 devices for Hichem Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hichem Diagnostics's devices?
Among its 41 most recently registered devices, Hichem Diagnostics has devices listed in FDA 510(k) (41 devices).
What risk classes do Hichem Diagnostics's devices fall under?
Among its 41 most recently registered devices, the classes recorded for Hichem Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hichem Diagnostics in the registry?
The most recently registered devices listed for Hichem Diagnostics include HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235), URIC ACID REAGENT (PRODUCT #88219), TRIGLYCERIDES REAGENT (PRODUCT #88218) and HICHEM LDH/L REAGENT KIT.