FDA.reportPublic FDA data

Anti-ER (Insite)

Primary DI
00850646007075
Brand
Anti-ER (Insite)
Company
BIOGENEX LABORATORIES
Model
AM368-5M
Catalog number
AM368-5M
Published
2016-09-23
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
00850646007075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850646007075008506460070758506460070750850646007075

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 Volume6Milliliter

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
00810119672421Anti-KRASAR751-5RAR751-5R2026-09-18
00840542207594Anti-CD2AM438-10MAM438-10M2026-09-18
00840542207600Anti-CD2AX438-50DAX438-50D2026-09-18
00840542207693Anti-Inhibin-AlphaAM446-10MAM446-10M2026-09-18
00840542207709Anti-Inhibin-AlphaAX446-50DAX446-50D2026-09-18
00840542207716Anti-Inhibin-AlphaAX446-YCDAX446-YCD2026-09-18
00840542210181Anti-CD90AN733-5MAN733-5M2026-09-18
00840542210198Anti-CD90AN733-10MAN733-10M2026-09-18
00840542210204Anti-CD90AY733-50DAY733-50D2026-09-18
00840542210211Anti-CD90AY733-YCDAY733-YCD2026-09-18
00840542210228Anti-CD90NU733-UCNU733-UC2026-09-18
00840542210235Anti-CD90NU733-5UCNU733-5UC2026-09-18
00840542210242Anti-CD53AN734-5MAN734-5M2026-09-18
00840542210259Anti-CD53AN734-10MAN734-10M2026-09-18
00840542210266Anti-CD53AY734-50DAY734-50D2026-09-18
00840542210372Anti-CD205AN737-10MEAN737-10ME2026-09-18
00840542210389Anti-CD205AY737-50DEAY737-50DE2026-09-18
00840542210396Anti-CD205AY737-YCDEAY737-YCDE2026-09-18
00840542210402Anti-CD205NU737-UCENU737-UCE2026-09-18
00840542210419Anti-CD205NU737-5UCENU737-5UCE2026-09-18

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