FDA.reportPublic FDA data

Rowley Biochemical Harris Hematoxylin

Primary DI
SO942852042008
Brand
Rowley Biochemical Harris Hematoxylin
Company
TRANSENE COMPANY, INC.
Model
1
Device description
Harris Hematoxylin without Mercury
Published
2019-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HZJStain, Papanicolau

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HZJStain, PapanicolauHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
SO942852042008PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematoxylin and eosin (H&E) stain control IVD, kitA prepared slide and/or other associated material used to verify the performance of a haematoxylin and eosin (H&E) stain/staining kit which is intended to be used for the demonstration of cell and tissue morphology in biological/clinical specimens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Gallon
Total Volume1Pint
Total Volume1Quart
Total Volume4Fluid Ounce
Total Volume8Fluid Ounce

Regulatory Flags#

DUNS number
044815983
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
SO471852042008Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution1SO-4712019-09-16
SO920852042008Rowley Biochemical Congo Red, 10% Aqueous12022-12-16
SO959852042008Rowley Biochemical Congo Red, 0.1% Aqueous1SO-9592019-09-16
E3021A852042008Rowley Biochemical Crystal Violet Working Solution1E-302-1A2019-09-16
E3031852042008Rowley Biochemical Sirius Red F3BA Solution1E-303-12019-09-16
E3101852042008Rowley Biochemical Carmine Stock1E-310-12019-09-16
E5852042008Rowley Biochemical Gelatin1E-52019-09-16
F3646852042008Rowley Biochemical Biebrich Scarlet Solution, 1%1F-364-42019-09-16
F3833852042008Rowley Biochemical Gomori's Chromium Hematoxylin1F-383-32019-09-16
R18852042008Rowley Biochemical Biebrich Scarlet, Certified1R-182019-09-16
R34852042008Rowley Biochemical Congo Red, Certified1R-342019-09-16
R36852042008Rowley Biochemical Crystal Violet, Certified1R-362019-09-16
R3852042008Alizarin Red, Certified1R-32019-09-16
R84852042008Rowley Biochemical Nuclear Fast Red1R-842019-09-16
SO1020852042008Rowley Biochemical Crystal Violet, 0.1% Solution1SO-10202019-09-16
SO1076852042008Rowley Biochemical Puchtler's Modification of Congo Red1SO-10762019-09-16
SO1077852042008Rowley Biochemical Sirius Red Solution1SO-10772019-09-16
SO1107852042008Rowley Biochemical Crystal Violet, 2% Aqueous1SO-11072019-09-16
SO1127852042008Rowley Biochemical Crystal Violet, 2.5% in 10% Alcohol1SO-11272019-09-16
SO1256852042008Rowley Biochemical Working Congo Red1SO-12562019-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693235747EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-09-04
00673693088206EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088213EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088244EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088251EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088268EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088275EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088282EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088305EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088312EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088329EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088343EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088367EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088374EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088381EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088404EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228534EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228541EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228558EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228565EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228572EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00613647023167FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HZJ2022-12-07
20613647023161FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HZJ2022-12-07
M8002852042008Rowley Biochemical Hydrochloric Acid 0.25%TRANSENE COMPANY, INC.HZJ2019-09-13
M8003852042008Rowley Biochemical Orange GTRANSENE COMPANY, INC.HZJ2019-09-13
M8015852042008Rowley Biochemical Modified Orange GTRANSENE COMPANY, INC.HZJ2019-09-13
SO323852042008Rowley Biochemical EA CounterstainTRANSENE COMPANY, INC.HZJ2019-09-13
SO430852042008Rowley Biochemical Scott's WaterTRANSENE COMPANY, INC.HZJ2019-09-13
15420045510159ThinPrepHologic, Inc.HZJ2018-08-15