FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647023167
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
220-105
Catalog number
22220105
Device description
CYTOSTAIN G 500ML/EA
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
20613647023161PackageGS11In Commercial Distribution
00613647023167PrimaryGS10
10613647023164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702316120613647023161
00613647023167006136470231676136470231670613647023167
1061364702316410613647023164

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.

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
4
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

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
20613647023161FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HZJ2022-12-07
SO942852042008Rowley Biochemical Harris HematoxylinTRANSENE COMPANY, INC.HZJ2019-09-13
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