FDA.reportPublic FDA data

ANTI-ESTROGEN RECEPTOR-ALPHA

Primary DI
00810119677655
Brand
ANTI-ESTROGEN RECEPTOR-ALPHA
Company
BIOGENEX LABORATORIES
Model
NU710-UC
Catalog number
NU710-UC
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810119677655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119677655008101196776558101196776550810119677655

GMDN Terms#

Term, Definition table
TermDefinition
Estrogen (oestrogen) receptor IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of estrogen (oestrogen) receptors in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 2-8°C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 421-4149support@biogenex.com

Regulatory Flags#

DUNS number
042697045
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
00840542209048Anti-Cytokeratin 4AM705-5MAM705-5M2026-09-16
00810119675866ANTI-MELAN-AAM361-10MAM361-10M2023-05-08
00810119677969ANTI-P16(INK4)AM540-10MAM540-10M2023-04-24
00810119678300TUMOR GLYCOPROTEINAM054-10MAM054-10M2023-04-24
00810119678430CALRETININPU413-UPPU413-UP2023-04-24
00810119678522MELANOMAAM001-10MAM001-10M2023-04-24
00810119677426ANTI-S-100 PROTEINPU058-UPPU058-UP2023-04-21
00810119677693Anti-CD99AY850-50DAY850-50D2023-04-21
00810119671783ANTI-CD7AM702-5MAM702-5M2023-04-05
00840542202070Anti-Hepatitis B Virus Core Antigen (HBcAg)AR082-10REAR082-10RE2026-09-21
00810119671912Anti-HIF-1 alphaANB27-5MANB27-5M2026-09-22
00810119672926Anti-Heat Shock Protein 27 (HSP 27)AM171-5MAM171-5M2026-09-22
00810119673206Anti-Collagen IIIAM167-5MAM167-5M2026-09-22
00810119674463Anti-Beta-Tubulin IIMU176-5UCMU176-5UC2026-09-22
00810119674531Anti-Beta-Tubulin IVMU178-5UCMU178-5UC2026-09-22
00810119675996Anti-Beta-Tubulin IVMU178-UCMU178-UC2026-09-22
00810119676016Anti-Beta-Tubulin IIIMU177-UCMU177-UC2026-09-22
00810119679000Anti-Collagen IIIMU167-UCMU167-UC2026-09-22
00810119679277Anti-Beta-Tubulin IVAM178-10MAM178-10M2026-09-22
00840542202094Anti-Hepatitis B Virus Core Antigen (HBcAg)AW082-YCDEAW082-YCDE2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810119676580ANTI-ESTROGEN RECEPTOR-ALPHABIOGENEX LABORATORIESMYA2023-05-16
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
00850646007105Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-09-26