FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832002611
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003801560
Device description
Harris Hematoxylin
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HYKHEMATOXYLIN HARRIS'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYKHematoxylin Harris'SHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849832002611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832002611008498320026118498320026110849832002611

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

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999tech.support@Leicabiosystems.com
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20849832027991Leica Biosystems39LP-300-239LP-300-22026-05-12
20849832028004Leica Biosystems39LP-300-339LP-300-32026-05-12
20849832028011Leica Biosystems39LP-300-439LP-300-42026-05-12
20849832028028Leica Biosystems39LP-300-539LP-300-52026-05-12
20849832028035Leica Biosystems39LP-300-639LP-300-62026-05-12
20849832028042Leica Biosystems39LP-300-739LP-300-72026-05-12
20849832028059Leica Biosystems39LP-400-039LP-400-02026-05-12
20849832028066Leica Biosystems39LP-400-139LP-400-12026-05-12
20849832028073Leica Biosystems39LP-400-239LP-400-22026-05-12
20849832028080Leica Biosystems39LP-400-339LP-400-32026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849832013112Leica BiosystemsLeica Biosystems Richmond, Inc.HYK2024-12-16
00673693088039EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693088046EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693088060EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228398EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228404EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228411EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228428EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04
00673693228497EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYK2024-09-04