Pierce Chemical Co.
Country not established
- Devices
- 10
What Pierce Chemical Co. makes
Pierce Chemical Co. manufactures in-vitro diagnostic (IVD) test kits for clinical chemistry, including rapid stat assays for triglycerides, bilirubin, uric acid, cholesterol (HDL), and microprotein levels. Their portfolio also includes glycated hemoglobin (HbA1c) testing kits, such as the Glyco-Gel and GlycoTest II, as well as a diagnostic kit for advanced clinical analysis labeled as Clinovative II. These products are designed for point-of-care and laboratory use to measure metabolic and biochemical markers.
The company’s diagnostic kits are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. Their products are listed in the FDA’s 510(k) database, adhering to U.S. regulatory requirements for in-vitro diagnostics. The manufacturer is based in the United States.
Catalogue
Glyco-Gel Test Kit Ref K820279
Regimes: 510(k) Registry: 510(k)Glycotest Ii Glyhb Assay Kit Ref K895661
Regimes: 510(k) Registry: 510(k)Triglyceride C-37 Rapid Stat Kit Ref K780825
Regimes: 510(k) Registry: 510(k)Bilirubin Rapid Stat Kit Ref K780826
Regimes: 510(k) Registry: 510(k)Uric Acid Rapid Stat Kit Ref K780827
Regimes: 510(k) Registry: 510(k)Cholesterol Rapid Slat Kit Hdl Ref K780331
Regimes: 510(k) Registry: 510(k)Auto/Stat Kit Ref K780512
Regimes: 510(k) Registry: 510(k)Glyco-Gel Test Kit Ref K821360
Regimes: 510(k) Registry: 510(k)Clinovative Ii Diagnostic Kit Ref K831837
Regimes: 510(k) Registry: 510(k)Stat Kit, Microprotein Ref K781897
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pierce Chemical Co. have in the registry?
The registry currently lists 10 devices for Pierce Chemical Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pierce Chemical Co.'s devices?
Among its 10 most recently registered devices, Pierce Chemical Co. has devices listed in FDA 510(k) (10 devices).
What risk classes do Pierce Chemical Co.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Pierce Chemical Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pierce Chemical Co. in the registry?
The most recently registered devices listed for Pierce Chemical Co. include GLYCO-GEL TEST KIT, GLYCOTEST II GLYHB ASSAY KIT, TRIGLYCERIDE C-37 RAPID STAT KIT and BILIRUBIN RAPID STAT KIT.