Canterbury Health Laboratories
New ZealandFDA applicant, unverified
- Devices
- 1
What Canterbury Health Laboratories makes
Canterbury Health Laboratories manufactures hemoglobin control products, specifically the Hemoglobin F & A2 Control for monitoring beta-thalassemia. This device is designed to assist in the quantitative measurement of fetal hemoglobin (HbF) and hemoglobin A2 (HbA2) levels in clinical laboratories.
The Hemoglobin F & A2 Control is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Canterbury Health Laboratories have in the registry?
The registry currently lists 1 device for Canterbury Health Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Canterbury Health Laboratories's devices?
Among its 1 most recently registered device, Canterbury Health Laboratories has devices listed in FDA 510(k) (1 device).
What risk classes do Canterbury Health Laboratories's devices fall under?
Among its 1 most recently registered device, the classes recorded for Canterbury Health Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Canterbury Health Laboratories in the registry?
The most recently registered devices listed for Canterbury Health Laboratories include HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL).