FDA.reportPublic FDA data

CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody

Primary DI
04015630972234
Brand
CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody
Company
Ventana Medical Systems, Inc.
Model
250 tests
Catalog number
05278414001
Published
2015-12-31
Public version status
Update
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
04015630972234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630972234040156309722344015630972234

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810119676580ANTI-ESTROGEN RECEPTOR-ALPHABIOGENEX LABORATORIESMYA2023-05-16
00810119677655ANTI-ESTROGEN RECEPTOR-ALPHABIOGENEX LABORATORIESMYA2023-04-21
05055331334107BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMYA2022-12-16
05055331334497BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMYA2022-12-16
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
00847627001870Estrogen Receptor (ER) [6F11]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