FDA.reportPublic FDA data

Anti-ER (Insite)

Primary DI
00850646007105
Brand
Anti-ER (Insite)
Company
BIOGENEX LABORATORIES
Model
AX368-50D
Catalog number
AX368-50D
Published
2016-09-26
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013148000BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)Biogenex Laboratories2002-02-28MYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850646007105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850646007105008506460071058506460071050850646007105

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)PU082-UPEPU082-UPE2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)PU082-5UPEPU082-5UPE2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)AR085-5REAR085-5RE2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)AR085-10REAR085-10RE2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)AW085-50DEAW085-50DE2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)AW085-YCDEAW085-YCDE2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)PU085-UPEPU085-UPE2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)PU085-5UPEPU085-5UPE2026-09-22
00840542202629Anti-Alpha-TubulinAM121-5MAM121-5M2026-09-22
00840542202636Anti-Alpha-TubulinAM121-10MAM121-10M2026-09-22

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