510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QZJClass III

Immunohistochemistry Assay, Antibody, Claudin 18

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

QZJ is the FDA product code for Immunohistochemistry Assay, Antibody, Claudin 18, a class III device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QZJ
Device name
Immunohistochemistry Assay, Antibody, Claudin 18
FDA 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.
Regulation
21 CFR 864.1860
Device class
Class III
Review panel
Hematology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code