Caltag Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Caltag Laboratories, Inc. makes
Caltag Laboratories, Inc. manufactures monoclonal antibody conjugates for flow cytometry, including fluorescently labeled combinations targeting immune cell markers such as CD3, CD4, CD8, CD19, and CD45. These products are designed for identifying and quantifying specific cell populations in hematological and immunological research. The company also provides a fetal hemoglobin test kit for detecting hemoglobin F levels in blood samples.
The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Caltag Laboratories, Inc. have in the registry?
The registry currently lists 12 devices for Caltag Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Caltag Laboratories, Inc.'s devices?
Among its 12 most recently registered devices, Caltag Laboratories, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Caltag Laboratories, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Caltag Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Caltag Laboratories, Inc. in the registry?
The most recently registered devices listed for Caltag Laboratories, Inc. include CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION, CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION, CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION and CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION.