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Spot-Light HER2 CISH Kit

by Invitrogen Corporation

PMA P050040

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 1 Jul 2008

PMA

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP050040 Date1 Jul 2008Approval withdrawnStatusWithdrawn

Recalls

1 recall · FDA

    • Terminated Z-0461-2012 FDA Unclassified (pre-2012) initiated 14 Nov 2011

    In vitro diagnostic reagent may be contaminated with a fungal contaminant.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Withdrawn

Specification

PMA

Generic Name
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
PMA Number
FDA Product Code
NYQ
Device Class
Class II
Regulation
21 CFR Part 864.1890
Advisory Committee
Pathology
FDA Decision
APWD Approval withdrawn

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