FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647023635
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
CS-432
Catalog number
CS432D
Device description
WRIGHT SURE STAIN 1QT
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
HYFGIEMSA STAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYFGiemsa StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647023635PackageGS11In Commercial Distribution
00613647023631PrimaryGS10
10613647023638Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702363520613647023635
00613647023631006136470236316136470236310613647023631
1061364702363810613647023638

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
12
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
00630414619248Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414619255Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323596Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323602Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
04015630971404Giemsa Staining KitVentana Medical Systems, Inc.HYF2025-12-15
00673693067782EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-06
00673693068192EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090353EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090377EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090414EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090421EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090438EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090445EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090476EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693236409EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693069564EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693069649EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693069700EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693069717EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236348EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236355EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236362EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236379EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236386EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236393EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00860011780526Chemical Service Labs, LLCProtean Resources, LLC.HYF2024-03-18
00860011780533Chemical Service Labs, LLCProtean Resources, LLC.HYF2024-03-18
00848838027086REMELREMEL, INC.HYF2022-12-23
00613647023631FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07
00613647023648FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07