FDA.reportPublic FDA data

BioSci™

Primary DI
06973471960668
Brand
BioSci™
Company
Shenzhen Dakewe Bio-engineering Co., Ltd
Model
Water-soluble
Device description
Eosin Staining Solution
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06973471960668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973471960668069734719606686973471960668

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.

Regulatory Flags#

DUNS number
543029175
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
16973471962171BioSciON2026-05-08
16973471962188BioSciON2026-05-08
16973471962195BioSciOO2026-05-08
16973471962201BioSciOO2026-05-08
16973471962218BioSciONO2026-05-08
16973471962225BioSciONO2026-05-08
16973471962232BioSciOM2026-05-08
16973471962249BioSciOM2026-05-08
16973471962256BioSciOM2026-05-08
16973471962263BioSciOM2026-05-08
16977644780029BioSci™VO69913212024-08-30
16977644780036BioSci™VNO69911912024-08-30
16977644780043BioSci™VNO69913912024-08-30
26977644780026BioSci™VO69913212024-08-30
26977644780033BioSci™VNO69911912024-08-30
26977644780040BioSci™VNO69913912024-08-30
16977644780012BioSci™VO69911212024-08-12
26977644780019BioSci™VO69911212024-08-12
16973471969941BioSci™VM69910142024-07-23
16973471969996BioSci™VN69911112024-07-23

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
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
00847627014443Rubens Eosin-PhloxineBIOCARE MEDICAL LLCHYB2022-12-07
00847627014436Edgar Degas EosinBIOCARE MEDICAL LLCHYB2022-09-23
04015630974757VENTANA HE 600 EosinVentana Medical Systems, Inc.HYB2021-08-31
07350025610191NidaconNidacon International ABHYB2017-12-15