FDA.reportPublic FDA data

20% Tween 20

Primary DI
00847627014665
Brand
20% Tween 20
Company
BIOCARE MEDICAL LLC
Model
TWN20H
Published
2022-12-07
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
JCCPh Buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847627014665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627014665008476270146658476270146650847627014665

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry wash buffer reagent IVDA substance or reactant intended to be used to perform a specific washing function in an enzyme immunohistochemistry assay performed on a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 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
00846405012442Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405014149Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405014156Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405016693Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405016709Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405016747Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405017355Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022281Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022298Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022304Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022311Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022328Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022335Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405023226Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405023936Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405012268Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405012275Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405017379Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405023301Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405023370Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405012213Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012220Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012237Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012244Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012251Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405023288Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405023295Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
04015630971008Antibody DiluentVentana Medical Systems, Inc.JCC2025-12-15
04015630972432ULTRA Cell Conditioning Solution (ULTRA CC1)Ventana Medical Systems, Inc.JCC2025-12-15
04015630985012ISH Probe DiluentVentana Medical Systems, Inc.JCC2025-12-15