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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceHercepTest™
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
# 1 Yishun Ave. 7
Singapore 768923
PMA NumberP980018
Supplement NumberS026
Date Received12/29/2025
Decision Date01/28/2026
Product Code MVC 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for specific labeling change to provide clearer instructions for use, which will improve user compliance and reduce errors, thereby ensuring consistent staining results.
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