FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647023161
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
00613647023167FisherbrandFISHER 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