FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832015789
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003801619
Device description
Eosin 515 LT
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
10849832015786PrimaryGS10
00849832015789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983201578610849832015786
00849832015789008498320157898498320157890849832015789

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849832001055Leica Biosystems39LC-705-439LC-705-42025-07-23
10849832003097Leica Biosystems39LC-705-339LC-705-32025-07-23
10849832024214Leica Biosystems380306538030652025-07-20
10849832024238Leica Biosystems380307538030752025-07-20
10849832024245Leica Biosystems380304538030452025-07-20
10849832024276Leica Biosystems380302538030252025-07-20
10849832025815Leica Biosystems39LC-705-139LC-705-12025-07-23
10849832025822Leica Biosystems39LC-705-239LC-705-22025-07-23
10849832025839Leica Biosystems39LC-705-539LC-705-52025-07-23
10849832027055Leica Biosystems380301538030152025-07-20
10849832027819Leica Biosystems380320038032002026-05-22
20849832027915Leica Biosystems39LP-200-239LP-200-22026-05-13
20849832027946Leica Biosystems39LP-200-539LP-200-52026-05-13
20849832027908Leica Biosystems39LP-200-139LP-200-12026-05-12
20849832027922Leica Biosystems39LP-200-339LP-200-32026-05-12
20849832027939Leica Biosystems39LP-200-439LP-200-42026-05-12
20849832027953Leica Biosystems39LP-200-639LP-200-62026-05-12
20849832027960Leica Biosystems39LP-200-739LP-200-72026-05-12
20849832027977Leica Biosystems39LP-300-039LP-300-02026-05-12
20849832027984Leica Biosystems39LP-300-139LP-300-12026-05-12

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
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
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