Skip to content

GeneSearch Breast Lymph Node (BLN) Assay

by Janssen Diagnostics

PMA P060017

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 16 Jul 2007

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP060017 Date16 Jul 2007Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Generic Name
RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
PMA Number
FDA Product Code
OCB
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APWD Approval withdrawn