FDA.reportPublic FDA data

FLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis)

Primary DI
05700571108147
Brand
FLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis)
Company
AGILENT TECHNOLOGIES, INC.
Model
GA084
Device description
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis)
Published
2018-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K170028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170028000FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/S2017-12-21MYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700571108147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700571108147057005711081475700571108147

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 Volume12Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544859500dako.dkregulatory@agilent.com

Regulatory Flags#

DUNS number
084963177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700575016899PD-L1 Control SlidesT13912026-04-29
05700573001736PD-L1 Control SlidesT13912020-11-17
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1M36752026-01-21
05700571102305Mono Mo A-Hu Progesterone Receptor, Cl PgR 636M35692016-09-16
05700571107713DakoGC2062024-08-07
05700575005213MLH1 IHC pharmDx (Dako Omnis)GE0792025-08-27
05700575005220MSH2 IHC pharmDx (Dako Omnis)GE0852025-08-27
05700575005237MSH6 IHC pharmDx (Dako Omnis)GE0862025-08-27
05700575005244PMS2 IHC pharmDx (Dako Omnis)GE0872025-08-27
05700575005251MMR Negative Control Reagent, Mouse (Dako Omnis)GE1012025-08-27
05700575005268MMR Negative Control Reagent, Rabbit (Dako Omnis)GE1022025-08-27
05700571102022Mono Mo A-Adrenocorticotropin (ACTH) Cl 02A3M35012020-09-17
05700571102053Mono Mo A-Hu Follicle Stimulating Hormone (FSH) Cl C10M35042020-09-17
05700571102190Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1M35392020-09-17
05700571102503Mono Mo A-Hu Tyrosinase Cl T311M36232020-09-17
05700571101933Mono Mo A-Thrombomodulin Cl 1009M06172020-09-17
05700571102039Mono Mo A-Hu Luteinizing Hormone (LH) Cl C93M35022020-09-17
05700571101995Mono Mo A-Hu Muscle Actin Cl HHF35M06352020-09-17
05700571105146Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294M35682016-09-16
05700571102046Mono Mo A-Hu Thyroid Stimulating Hormone (TSH) Cl 0042M35032020-09-17

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
00850646007143Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-10-14
00850646007150Anti-ERBIOGENEX LABORATORIESMYA2016-10-14
00850646007105Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-09-26