← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

QUL — Immunohistochemistry Assay, Antibody, Folr1

The FOLR1 antibody is a qualitative immunohistochemical antibody intended to identify FOLR1 protein expression in human clinical tissue specimens. The FOLR-1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

DEVICE CLASS
Class III
REGULATION
21 CFR 864.1860
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
PA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P220006Ventana Medical Systems, Inc. · pma2025-06-20

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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