Cytotech, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 10
What Cytotech, Inc. makes
Cytotech, Inc. manufactures diagnostic immunoassay kits and controls for detecting and measuring specific antibodies and immune complexes in patient samples. Products include indirect immunofluorescence assays for antinuclear antibodies (ANA), enzyme immunoassays (EIA) for herpes simplex virus (HSV), rubella, cytomegalovirus (CMV), toxoplasma, and C1-inhibitor, as well as controls for circulating immune complexes (CIC). The portfolio also features a CIC-Raji cell replacement enzyme immunoassay for immune complex detection.
The company’s diagnostic devices fall under Class II risk classification in the US and are listed in the FDA 510(k) registry. These products are intended for in vitro diagnostic use and comply with US regulatory requirements for medical devices. The manufacturer is based in the United States.
Catalogue
Cytotech Antinuclear Antibody (Ana) Ifa Kit Ref K871801
510(k) 510(k)Antinuclear Antibody (Ana) Positive Controls Ref K873249
510(k) 510(k)Cytotech Hsv Igg Enzyme Immunoassay Ref K862838
510(k) 510(k)Cytotech Rubella Igg Enzyme Immunoassay Ref K864315
510(k) 510(k)Circulating Immune Complexes Controls Ref K882829
510(k) 510(k)Cytotech C1-Inhibitor Enzyme Immunoassay Ref K872426
510(k) 510(k)Cic-Raji Cell Replacement Enzyme Immunoassay Ref K874379
510(k) 510(k)Cytotech Toxoplasma Igg Enzyme Immunoassay Ref K863363
510(k) 510(k)Cytotech Cmv Igg Eia Ref K860493
510(k) 510(k)Cytotech Cic Enzyme Immunoassay Ref K862649
510(k) 510(k)
Frequently asked questions
How many devices does Cytotech, Inc. have in the registry?
The registry currently lists 10 devices for Cytotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cytotech, Inc.'s devices?
Among its 10 most recently registered devices, Cytotech, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Cytotech, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Cytotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cytotech, Inc. in the registry?
The most recently registered devices listed for Cytotech, Inc. include CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT, ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS, CYTOTECH HSV IGG ENZYME IMMUNOASSAY and CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY.