PMA P050040S002

Device: SPOT-LIGHT HER2 CISH KIT
Applicant: Invitrogen Corporation
PMA number: P050040
Supplement: S002
Product code: NYQ
Decision date: 2011-04-29
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Approval order statement: APPROVAL FOR CHANGES IN THE PRODUCT INSERT: 1) MANUFACTURING ADDRESS CHANGE; 2) COPYRIGHT CHANGE FROM INVITROGEN CORPORATION TO LIFE TECHNOLOGIES. INVITROGEN WILL REMAIN THE BRAND NAME AND THEREFORE IS STILL INCLUDED ON THE PRODUCT INSERT AND LABELING; AND AN ADDITION OF LITERATURE REFERENCES TO THE BIBLIOGRAPHY.

Current openFDA PMA Record#

Device: SPOT-LIGHT HER2 CISH KIT
Applicant: Invitrogen Corporation
PMA number: P050040
Supplement: S002
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Decision date: 2011-04-29
Decision code: APPR
Date received: 2011-03-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES IN THE PRODUCT INSERT: 1) MANUFACTURING ADDRESS CHANGE; 2) COPYRIGHT CHANGE FROM INVITROGEN CORPORATION TO LIFE TECHNOLOGIES. INVITROGEN WILL REMAIN THE BRAND NAME AND THEREFORE IS STILL INCLUDED ON THE PRODUCT INSERT AND LABELING; AND AN ADDITION OF LITERATURE REFERENCES TO THE BIBLIOGRAPHY.