Cis-US, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Cis-US, Inc. makes
Cis-Us, Inc. manufactures radioactive sources, including the Cesium-137 source (CSM-40) and an irradiator for biological materials (IBL-137C), as well as high-dose rate brachytherapy devices like the Curietron 192. The company also produces immunoradiometric assay kits for thyroid hormones (ELSA-PTH, ELSA-TSH) and hematological markers (ELSA-HCT), alongside a personnel protective shield for radiation safety. Additional offerings include the ELSA-PROL immunoradiometric assay kit and the Venticis II, a device likely used in medical imaging or radiation therapy.
The company’s products are regulated under FDA 510(k) clearance requirements, with devices classified as Class I, Class II, and Unclassified (U). These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Cis-Us, Inc. is headquartered in the United States.
Catalogue
Cesium 137 Source, Model Csm-40 Ref K882449
Regimes: 510(k) Registry: 510(k)Elsa-Prol Immunoradiometric Assay Kit Ref K860823
Regimes: 510(k) Registry: 510(k)Elsa-Pth Ref K950211
Regimes: 510(k) Registry: 510(k)Tshk-Nn Ria Kit Ref K860824
Regimes: 510(k) Registry: 510(k)Irradiator For Biological Materials, Ibl-137C Ref K865027
Regimes: 510(k) Registry: 510(k)Personnel Protective Shield Ref K871502
Regimes: 510(k) Registry: 510(k)Elsa-Hct Ref K951708
Regimes: 510(k) Registry: 510(k)Venticis Ii Ref K863778
Regimes: 510(k) Registry: 510(k)Curietron 192 High Dose Rate Ref K890799
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cis-Us, Inc. have in the registry?
The registry currently lists 9 devices for Cis-Us, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cis-Us, Inc.'s devices?
Among its 9 most recently registered devices, Cis-Us, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Cis-Us, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Cis-Us, 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-Us, Inc. in the registry?
The most recently registered devices listed for Cis-Us, Inc. include CESIUM 137 SOURCE, MODEL CSM-40, ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT, ELSA-PTH and TSHK-NN RIA KIT.