Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHER2FISH PHARMDX KIT
Generic NameSYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
ApplicantAgilent Technologies Singapore (International) Pte Ltd.
No. 1 Yishun Avenue 7
Singapore 76892
PMA NumberP040005
Supplement NumberS003
Date Received07/10/2008
Decision Date10/10/2008
Product Code MVD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES:1. LABELING CHANGE IN THE STEP 1 (PRE-TREATMENT) IN THE INSTRUCTIONS FOR USE TO INCLUDE ANALTERNATIVE METHOD TO HEAT THE PRE-TREATMENT BUFFER USING A MICROWAVE OVEN WITH BOILSENSOR CAPABILITY AS "WATER BATH" INDEPENDENTLY OF THE BUFFER START VOLUME ANDTEMPERATURE2. LABELING CHANGE IN THE STEP 2 (PEPSIN, READY-TO-USE) IN THE INSTRUCTIONS FOR USE TO INCLUDEAN ALTERNATIVE METHOD OF INCUBATION WITH PEPSIN USING A HEATING BLOCK, E.G. A HYBRIDIZER,AND INCUBATION AT 37°C AS AN ALTERNATIVE TO INCUBATION AT ROOM TEMPERATURE3. CHANGES IN REAGENT VOLUME AND VIAL SIZE FOR VIAL 1 AND VIAL 24. MODIFICATION OF SIGNAL COUNTING GUIDE TO INCLUDE UNDER-DIGESTED NUCLEI5. LABELING CHANGE IN THE INSTRUCTIONS FOR USE TO INCLUDE THE DAKO HYBRIDIZER AS ANALTERNATIVE TO THE USE OF HEATING BLOCK AND HYBRIDIZATION OVEN FOR DENATURATION ANDHYBRIDIZATION STEPS, RESPECTIVELY.
-
-