Cis Radiopharmaceuticals, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What Cis Radiopharmaceuticals, Inc. makes
Cis Radiopharmaceuticals, Inc. manufactures diagnostic radioimmunoassay (RIA) kits for measuring hormones and proteins, including ferritin, progesterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, myoglobin, and trypsin. The company also produces iridium-192 wires and pins for medical brachytherapy applications, as well as oral administration sets for radiopharmaceutical use.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with relevant submissions recorded in the 510(k) premarket notification database. These devices are listed in the U.S. under FDA jurisdiction, adhering to applicable radiopharmaceutical and diagnostic testing regulations.
Catalogue
Ferritin Ria Kit Ref K791860
510(k) 510(k)Progesterone Radioimmunoassay Kit Ref K791051
510(k) 510(k)Iridium 192 Wires & Pins Ref K771878
510(k) 510(k)Luteinizing Hormone (Lh) Ria Ref K792000
510(k) 510(k)Kits, Ria, Myoglobin, Human, Measurement Ref K780982
510(k) 510(k)Follicle Stimulating Hormone (Fsh) Kit Ref K792063
510(k) 510(k)Set, Oral Administration Ref K760251
510(k) 510(k)Ria Kit For Trypsin Ref K791202
510(k) 510(k)Ria Kit, Prolactin Ref K790003
510(k) 510(k)
Frequently asked questions
How many devices does Cis Radiopharmaceuticals, Inc. have in the registry?
The registry currently lists 9 devices for Cis Radiopharmaceuticals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cis Radiopharmaceuticals, Inc.'s devices?
Among its 9 most recently registered devices, Cis Radiopharmaceuticals, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Cis Radiopharmaceuticals, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Cis Radiopharmaceuticals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cis Radiopharmaceuticals, Inc. in the registry?
The most recently registered devices listed for Cis Radiopharmaceuticals, Inc. include FERRITIN RIA KIT, PROGESTERONE RADIOIMMUNOASSAY KIT, IRIDIUM 192 WIRES & PINS and LUTEINIZING HORMONE (LH) RIA.