FDA.reportPublic FDA data

HER2/neu [IHC042]

Primary DI
00847627041999
Brand
HER2/neu [IHC042]
Company
BIOCARE MEDICAL LLC
Model
NPAA3274T40
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MVCSystem, Test, Her-2/Neu, Ihc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVCSystem, Test, Her-2/Neu, IhcUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847627041999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627041999008476270419998476270419990847627041999

GMDN Terms#

Term, Definition table
TermDefinition
Human epidermal growth factor receptor 2 (HER2) protein IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806617825
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847627051622CK HMW + p63 + AMACR (RM)ALI3154DSG25 2026-05-14
00847627051639CK HMW + p63 + AMACR (RM)ALI3154DSL2026-05-14
00847627046147Treponema pallidum (Spirochete)APA135H2026-04-14
00847627040664SALL4NPAI384T402026-04-01
00847627041036Cyclin D1NPAI432T40 2026-04-01
00847627042095Carcinoembryonic Antigen (CEA{M})NPAI058T402026-04-01
00847627042194Caspase-3 (Cleaved)NPAI229T402026-04-01
00847627042590S100PNPAI3010T402026-04-01
00847627042859CD33NPAI3116T40 2026-04-01
00847627043726NeoPath Background Punisher NPRI10029T402026-03-11
00847627042637Pan TRK [RM423]NPAI3267T402026-02-19
00847627042279CK7NPAI339T402026-01-29
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitNPRI10097KT135 2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitNPRI10101KT1352026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)NPRI10106T50 2026-01-29
00847627042033DesminNPAI036T402026-01-13
00847627042835CD19NPAI310T402026-01-13
00847627041937Myeloperoxidase (P)NPAI023T402026-01-06
00847627042514VimentinNPAI048T402026-01-06
00847627042019CD43NPAI005T402025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055331301291BOND ORACLE HER2 IHC SystemLEICA BIOSYSTEMS NEWCASTLE LTDMVC2014-09-23
04015630972289PATHWAY HER-2 4 in 1 Control SlidesVentana Medical Systems, Inc.MVC2014-09-16
05700572031987HercepTest™AGILENT TECHNOLOGIES SINGAPORE PTE LTDMVC2014-09-15
05700572031994HercepTest™ for the Dako AutostainerAGILENT TECHNOLOGIES SINGAPORE PTE LTDMVC2014-09-15
05700572032007HercepTest™ for Automated Link PlarformsAGILENT TECHNOLOGIES SINGAPORE PTE LTDMVC2014-09-15
04015630972197PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.MVC2014-09-11