Canadian Bioclinical, Ltd.
CanadaFDA applicant, unverified
- Devices
- 4
What Canadian Bioclinical, Ltd. makes
Canadian Bioclinical, Ltd. manufactures coated tube radioimmunoassay (RIA) kits for laboratory testing, including kits for measuring HCG, total T3, digoxin, and cortisol levels. The company also produces a home pregnancy test, the ANI BIOCARD™ HCG Test, designed for point-of-care use.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Ani Biocard(Tm) Hcg Test Ref K933794
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Digoxin/Ria Kit Coated Tube Radioimmunoassay Kit Ref K864449
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Canadian Bioclinical, Ltd. have in the registry?
The registry currently lists 4 devices for Canadian Bioclinical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Canadian Bioclinical, Ltd.'s devices?
Among its 4 most recently registered devices, Canadian Bioclinical, Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Canadian Bioclinical, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Canadian Bioclinical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Canadian Bioclinical, Ltd. in the registry?
The most recently registered devices listed for Canadian Bioclinical, Ltd. include ANI BIOCARD(TM) HCG TEST, TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT, DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT and CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT.