FDA.reportPublic FDA data

Anti-PR (Insite)

Primary DI
00850646007020
Brand
Anti-PR (Insite)
Company
BIOGENEX LABORATORIES
Model
AM328-10M
Catalog number
AM328-10M
Published
2016-09-23
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
00850646007020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850646007020008506460070208506460070200850646007020

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 Volume10Milliliter

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
00810119672421Anti-KRASAR751-5RAR751-5R2026-09-18
00840542207594Anti-CD2AM438-10MAM438-10M2026-09-18
00840542207600Anti-CD2AX438-50DAX438-50D2026-09-18
00840542207693Anti-Inhibin-AlphaAM446-10MAM446-10M2026-09-18
00840542207709Anti-Inhibin-AlphaAX446-50DAX446-50D2026-09-18
00840542207716Anti-Inhibin-AlphaAX446-YCDAX446-YCD2026-09-18
00840542210181Anti-CD90AN733-5MAN733-5M2026-09-18
00840542210198Anti-CD90AN733-10MAN733-10M2026-09-18
00840542210204Anti-CD90AY733-50DAY733-50D2026-09-18
00840542210211Anti-CD90AY733-YCDAY733-YCD2026-09-18
00840542210228Anti-CD90NU733-UCNU733-UC2026-09-18
00840542210235Anti-CD90NU733-5UCNU733-5UC2026-09-18
00840542210242Anti-CD53AN734-5MAN734-5M2026-09-18
00840542210259Anti-CD53AN734-10MAN734-10M2026-09-18
00840542210266Anti-CD53AY734-50DAY734-50D2026-09-18
00840542210372Anti-CD205AN737-10MEAN737-10ME2026-09-18
00840542210389Anti-CD205AY737-50DEAY737-50DE2026-09-18
00840542210396Anti-CD205AY737-YCDEAY737-YCDE2026-09-18
00840542210402Anti-CD205NU737-UCENU737-UCE2026-09-18
00840542210419Anti-CD205NU737-5UCENU737-5UCE2026-09-18

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
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