FDA.reportPublic FDA data

MCM2 + TOP2A

Primary DI
00847627039590
Brand
MCM2 + TOP2A
Company
BIOCARE MEDICAL LLC
Model
NPAI3181T80
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847627039590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627039590008476270395908476270395900847627039590

GMDN Terms#

Term, Definition table
TermDefinition
Multiple solid tumour differentiation marker IVD, antibodyMultiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid tumour (e.g., lung, breast, ovarian, kidney, gastrointestinal, colon) in a clinical specimen. It is typically used in cancer-screening assays to help diagnostic differentiation between solid tumour types through detection of various types of proteins/markers (e.g., homeobox protein CDX-2, cytokeratin 7, GATA3, uroplakin).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806617825
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847627051622CK HMW + p63 + AMACR (RM)ALI3154DSG25 2026-05-14
00847627051639CK HMW + p63 + AMACR (RM)ALI3154DSL2026-05-14
00847627046147Treponema pallidum (Spirochete)APA135H2026-04-14
00847627040664SALL4NPAI384T402026-04-01
00847627041036Cyclin D1NPAI432T40 2026-04-01
00847627042095Carcinoembryonic Antigen (CEA{M})NPAI058T402026-04-01
00847627042194Caspase-3 (Cleaved)NPAI229T402026-04-01
00847627042590S100PNPAI3010T402026-04-01
00847627042859CD33NPAI3116T40 2026-04-01
00847627043726NeoPath Background Punisher NPRI10029T402026-03-11
00847627042637Pan TRK [RM423]NPAI3267T402026-02-19
00847627042279CK7NPAI339T402026-01-29
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitNPRI10097KT135 2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitNPRI10101KT1352026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)NPRI10106T50 2026-01-29
00847627042033DesminNPAI036T402026-01-13
00847627042835CD19NPAI310T402026-01-13
00847627041937Myeloperoxidase (P)NPAI023T402026-01-06
00847627042514VimentinNPAI048T402026-01-06
00847627041999HER2/neu [IHC042]NPAA3274T402025-12-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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