FDA.reportPublic FDA data

BOND

Primary DI
05055331320339
Brand
BOND
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0436
Catalog number
PA0436
Device description
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems.
Published
2020-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXZImmunohistochemistry Assay, Antibody, Progesterone ReceptorHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055331320339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331320339050553313203395055331320339

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.

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
+1(800)2480123tech.support@leicabiosystems.com

Regulatory Flags#

DUNS number
397134693
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055331339607BONDPA0678-UPA0678-U2026-04-10
05055331316967Novocastra™AE1/AE3-L-CENCL-L-AE1/AE32022-12-07
08718858480791Kreatech FISH probes22Q003B4952022-09-21
08718858481231Kreatech FISH probes02P009V5502022-09-21
08718858481248Kreatech FISH probes03Q009V49503Q009V4952022-09-21
08718858481774Kreatech FISH probes02P008V4952022-09-21
08718858481668Kreatech FISH probes03Q001B5502022-08-08
08718858481675Kreatech FISH probes03Q002B4952022-08-08
08718858481712Kreatech FISH probes13Q002C4952022-08-08
08718858481729Kreatech FISH probes14Q001C4152022-08-08
08718858481736Kreatech FISH probes16Q001B4952022-08-08
08718858481743Kreatech FISH probes23P004C5502022-08-08
08718858481798Kreatech FISH probes04Q001B5502022-08-08
08718858481804Kreatech FISH probes04Q005B5502022-08-08
08718858481811Kreatech FISH probes08C001B4952022-08-08
08718858481880Kreatech FISH probes01P003B5502022-08-08
08718858481958Kreatech FISH probes04C001B4952022-08-08
08718858480029Kreatech FISH probes06Q003B4952022-08-05
08718858480036Kreatech FISH probes10Q001B4952022-08-05
08718858481613Kreatech FISH probes14Q001B5502022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847627037824Progesterone Receptor (PR) [16]BIOCARE MEDICAL LLCMXZ2025-03-20
00810119676627ANTI-HUMAN PROGESTERONE RECEPTORBIOGENEX LABORATORIESMXZ2023-05-16
05055331334855BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMXZ2022-12-16
05055331335104BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMXZ2022-12-16
00847627002020Progesterone Receptor (PR) [PgR636]BIOCARE MEDICAL LLCMXZ2022-12-13
00847627002037Progesterone Receptor (PR) [PgR636]BIOCARE MEDICAL LLCMXZ2022-12-13
00847627031693Progesterone Receptor [PgR636]BIOCARE MEDICAL LLCMXZ2022-12-13
00847627001986Progesterone Receptor (PR) [SP2]BIOCARE MEDICAL LLCMXZ2022-12-13
05700571108154FLEX Mono Mo A-Hu Progesterone Receptor Cl PgR 1294 RTU (Dako Omnis)AGILENT TECHNOLOGIES, INC.MXZ2018-03-01
05700571101759FLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link)AGILENT TECHNOLOGIES, INC.MXZ2017-01-03
00850646007129Anti-PR (Insite)BIOGENEX LABORATORIESMXZ2016-10-14
00850646007136Anti-PRBIOGENEX LABORATORIESMXZ2016-10-14
05055331303158Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDMXZ2016-09-24
05055331304292BOND™LEICA BIOSYSTEMS NEWCASTLE LTDMXZ2016-09-24
00850646007006Anti-PR (Insite)BIOGENEX LABORATORIESMXZ2016-09-23
00850646007013Anti-PR (Insite)BIOGENEX LABORATORIESMXZ2016-09-23
00850646007020Anti-PR (Insite)BIOGENEX LABORATORIESMXZ2016-09-23
00850646007037Anti-PR (Insite)BIOGENEX LABORATORIESMXZ2016-09-23
00850646007044Anti-PR (Insite)BIOGENEX LABORATORIESMXZ2016-09-23
00850646007051Anti-PR (Insite)BIOGENEX LABORATORIESMXZ2016-09-23
00673693180337Progesterone Receptor Ready to use IHC (UVLP)RICHARD-ALLAN SCIENTIFIC COMPANYMXZ2016-09-21
00673693180344Progesterone Receptor Culture Supernatant with azideRICHARD-ALLAN SCIENTIFIC COMPANYMXZ2016-09-21
00673693402859Progesterone Receptor Culture Supernatant with azideRICHARD-ALLAN SCIENTIFIC COMPANYMXZ2016-09-21
00673693402866Progesterone Receptor Culture Supernatant with azideRICHARD-ALLAN SCIENTIFIC COMPANYMXZ2016-09-21
00673693559577Progesterone Receptor Ready to use IHC (Quanto)RICHARD-ALLAN SCIENTIFIC COMPANYMXZ2016-09-21
05700571102299Mono Mo A-Hu Progesterone Receptor, Cl PgR 636AGILENT TECHNOLOGIES, INC.MXZ2016-09-16
05700571102305Mono Mo A-Hu Progesterone Receptor, Cl PgR 636AGILENT TECHNOLOGIES, INC.MXZ2016-09-16
05700571104354Dako ER/PR pharmDx Kit For the Dako AutostainerAGILENT TECHNOLOGIES, INC.MXZ2016-09-16
05700571104897Dako ER/PR pharmDx Kit (Link)AGILENT TECHNOLOGIES, INC.MXZ2016-09-16
05700571105146Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294AGILENT TECHNOLOGIES, INC.MXZ2016-09-16