FDA.reportPublic FDA data

Fluoro Care Anti-Fade Mountant

Primary DI
00847627002464
Brand
Fluoro Care Anti-Fade Mountant
Company
BIOCARE MEDICAL LLC
Model
FP001G10
Published
2022-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LEBMounting Media

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEBMounting MediaPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847627002464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627002464008476270024648476270024640847627002464

GMDN Terms#

Term, Definition table
TermDefinition
Microscopy mounting medium IVDA substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip to preserve the specimen and enhance image quality during microscopic examination.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806617825
Device count
1
Premarket exempt
true
Kit
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
04049016151982Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
04049016152002Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
00613647028612FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00613647028650FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028616FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028654FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00860012688937ClaraMount™ Coverslip mounting mediumClarapath, Inc.LEB2024-08-23
00673693073189EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088947EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
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