FDA.reportPublic FDA data

Estrogen Receptor (ER) [6F11]

Primary DI
00847627001870
Brand
Estrogen Receptor (ER) [6F11]
Company
BIOCARE MEDICAL LLC
Model
APA093AA
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYAImmunohistochemistry Antibody Assay, Estrogen Receptor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYAImmunohistochemistry Antibody Assay, Estrogen ReceptorHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847627001870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627001870008476270018708476270018700847627001870

GMDN Terms#

Term, Definition table
TermDefinition
Estrogen (oestrogen)/progesterone receptor 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 estrogen (oestrogen) and/or progesterone receptors 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
00847627041999HER2/neu [IHC042]NPAA3274T402025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810119677655ANTI-ESTROGEN RECEPTOR-ALPHABIOGENEX LABORATORIESMYA2023-04-21
00847627001290Estrogen Receptor (ER) [1D5]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001306Estrogen Receptor (ER) [1D5]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001313Estrogen Receptor (ER) [6F11]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001412Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001511Estrogen Receptor (ER) [1D5]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001528Estrogen Receptor (ER) [1D5]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001535Estrogen Receptor (ER) [6F11]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001610Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001627Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001634Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001863Estrogen Receptor (ER) [1D5]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001955Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627001993Estrogen Receptor (ER) [6F11 + SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627002006Estrogen Receptor (ER) [6F11 + SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627002044Estrogen Receptor (ER) [1D5]BIOCARE MEDICAL LLCMYA2022-12-07
00847627002051Estrogen Receptor (ER) [6F11]BIOCARE MEDICAL LLCMYA2022-12-07
00847627002105Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627002266Estrogen Receptor (ER) [6F11 + SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627002273Estrogen Receptor (ER) [6F11 + SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627024602Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
00847627029164Estrogen Receptor (ER) [SP1]BIOCARE MEDICAL LLCMYA2022-12-07
05055331325211BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMYA2021-03-19
05700571108147FLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis)AGILENT TECHNOLOGIES, INC.MYA2018-03-01
00850646007143Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-10-14
00850646007150Anti-ERBIOGENEX LABORATORIESMYA2016-10-14
00850646007105Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-09-26
00850646007112Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-09-26
05055331304575BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMYA2016-09-24
05055331309600Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDMYA2016-09-24