FDA.reportPublic FDA data

Pan Melanoma Cocktail-2

Primary DI
00847627042965
Brand
Pan Melanoma Cocktail-2
Company
BIOCARE MEDICAL LLC
Model
PM178H
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00847627042965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627042965008476270429658476270429650847627042965

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841683151340Arginase-1 SP156 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151364CD163 MRQ-26 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151371Cytokeratin 5 & 6 D5 & 16B4 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151388Ep-CAM MOC31 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151395GATA3 L50-823 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151401Glypican-3 1G12 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151418Hepatocyte Specific Antigen (Hep-Par 1) OCH1E5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151425IgG4 MRQ-44 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151432Mammaglobin 31A5 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151449Microphthalmia Transcription Factor (MiTF) C5/D5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151463Napsin A MRQ-60 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151470p120 Catenin MRQ-5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151487PAX8 MRQ-50 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151494PHH3 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151517Podoplanin D2-40 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151524Renal Cell Carcinoma PN-15 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151531S100 Protein 4C4.9 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151548SOX-10 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151555SOX-11 MRQ-58 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151562SOX-2 SP76 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151579C4d SP91 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
04065271108967Claudin-4 (EP417) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-04
00846405016808Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016822Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016839Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016846Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020102Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020119Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020126Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020133Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09