Amersham Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 94
What Amersham Corp. makes
Amersham Corp. manufactures in vitro diagnostic assays, including lateral flow and test kits for thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, and anti-double-stranded DNA (anti-DSDNA). The company also produces radiopharmaceutical sources like gadolinium-153 for bone densitometry and cesium-137 microseed assemblies for medical imaging and brachytherapy applications.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. These products are intended for laboratory and clinical use in the United States.
Catalogue
Search and filter all 94 devicesShowing 1-50 of 94
Frequently asked questions
How many devices does Amersham Corp. have in the registry?
The registry currently lists 94 devices for Amersham Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amersham Corp.'s devices?
Among its 50 most recently registered devices, Amersham Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Amersham Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Amersham Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amersham Corp. in the registry?
The most recently registered devices listed for Amersham Corp. include AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT, AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST, AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST and AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE).