FDA.reportPublic FDA data

CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody

Primary DI
04015630972203
Brand
CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody
Company
Ventana Medical Systems, Inc.
Model
250 tests
Catalog number
05278392001
Published
2015-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04015630972203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630972203040156309722034015630972203

GMDN Terms#

Term, Definition table
TermDefinition
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 progesterone receptors in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20

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
05055331320339BONDLEICA BIOSYSTEMS NEWCASTLE LTDMXZ2020-04-07
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