Immunohistochemistry Assay, Antibody, Claudin 18

QZJ · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860

Classification

FDA Product Code: QZJ
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: 21 CFR 864.1860
Review panel: PA
Medical specialty: Hematology
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown