Product code QZJ
- Device name
- Immunohistochemistry Assay, Antibody, Claudin 18
- Medical specialty
- Hematology
- Device class
- 3
- Regulation number
- 864.1860
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The Claudin 18 antibody is a qualitative immunohistochemical antibody intended to identify CLDN18 protein expression in human clinical tissue specimens. The CLDN18 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
- Source
- FDA openFDA device classification dataset