FDA.reportPublic FDA data

Rubens Eosin-Phloxine

Primary DI
00847627014443
Brand
Rubens Eosin-Phloxine
Company
BIOCARE MEDICAL LLC
Model
HTEP-GL
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
HYBEosin Y

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYBEosin YHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847627014443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627014443008476270144438476270144430847627014443

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

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
10849832015786Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
00849832002642Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
00849832017981Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
00849832015789Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
10849832015779Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-16
00849832013099Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-16
00673693087346EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087360EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087377EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087384EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087391EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087407EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087445EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228503EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228510EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228589EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228596EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228602EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228619EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693483209EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
06973471960668BioSci™Shenzhen Dakewe Bio-engineering Co., LtdHYB2023-09-12
07290012140891QwikCheck Vitality KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.HYB2023-06-08
00613647023150FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYB2022-12-07
20613647023154FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYB2022-12-07
00847627014436Edgar Degas EosinBIOCARE MEDICAL LLCHYB2022-09-23
04015630974757VENTANA HE 600 EosinVentana Medical Systems, Inc.HYB2021-08-31
07350025610191NidaconNidacon International ABHYB2017-12-15