FDA.report

Estrogen Receptor (ER) [6F11 + SP1]

Primary DI
00847627002006
Brand
Estrogen Receptor (ER) [6F11 + SP1]
Company
BIOCARE MEDICAL LLC
Model
APA308H
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MYAImmunohistochemistry Antibody Assay, Estrogen Receptor

Product Code Classifications

CodeDeviceSpecialtyClass
MYAImmunohistochemistry Antibody Assay, Estrogen ReceptorHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847627002006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627002006008476270020068476270020060847627002006

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
806617825
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00847627042491CD79aNPAI067T402025-12-16
00847627042576Cytokeratin [AE1] LMWNPAI081T402025-12-16
00847627042897CD103 (RM)NPAI3117T402025-12-16
00847627042071Mammaglobin (M)NPAI269T402025-11-25
00847627042132CD7NPAI158T402025-11-25
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810119677655ANTI-ESTROGEN RECEPTOR-ALPHABIOGENEX LABORATORIESMYA2023-04-21
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
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
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00850646007143Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-10-14
00850646007150Anti-ERBIOGENEX LABORATORIESMYA2016-10-14
00850646007105Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-09-26
00850646007112Anti-ER (Insite)BIOGENEX LABORATORIESMYA2016-09-26
05055331304575BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMYA2016-09-24
05055331309600Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDMYA2016-09-24