FDA.reportPublic FDA data

Anti-PR (Insite)

Primary DI
00850646007129
Brand
Anti-PR (Insite)
Company
BIOGENEX LABORATORIES
Model
AM328-5MSG
Catalog number
AM328-5MSG
Published
2016-10-14
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
MXZImmunohistochemistry Assay,Antibody,Progesterone Receptor

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012960000BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORBiogenex Laboratories2002-03-08MXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850646007129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850646007129008506460071298506460071290850646007129

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

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
00810119676733ANTI-HER2/ERBB2AY726-YCDAY726-YCD2023-05-04
00810119679062ANTI-C-ERBB-2NU753-UCNU753-UC2023-04-25
00810119677433Anti- HER2/ERBB2 PHOSPHO (PY877)NU726-UCNU726-UC2023-04-21
00810119676443ANTI-HER2/ERBB2AN726-5MAN726-5M2023-04-20
00810119674395ANTI- HER2/ERBB2NU726-5UCNU726-5UC2023-04-19
00810119674562ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-19
00810119674890ANTI- HER2/ERBB2NU726-UCNU726-UC2023-04-19
00810119673541ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-18
00810119671363ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-04-03
00810119674876ANTI-C-ERBB-2 (HER-2/NEU)MU134-UCMU134-UC2023-03-29
00810119670069ANTI-HER2/ERBB2AN726-5MAN726-5M2023-03-28
00810119670373ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-03-28
00810119670168ANTI-HER2/ERBB2AN726-10MAN726-10M2023-03-27
00810119673923ANTI-VIPAR530-5RAR530-5R2023-05-12
00810119678713ANTI-VIPPU530-UPPU530-UP2023-04-24
00810119673169ANTI-TAUAM412-5MAM412-5M2023-04-17
00810119672513ANTI-TAUAM459-5MAM459-5M2023-04-06
00810119671202ANTI-BETA-HCGAM395-5MAM395-5M2023-03-31
00810119673411TRIS WASH BUFFERHK098-5KHK098-5K2023-05-12
00850646007341DiluentHK156-5KEHK156-5KE2023-05-19

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
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