FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647023123
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
220-101
Catalog number
22220101
Device description
PINNACLE 1 HEMATOXYLIN 500ML
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
HYJHEMATOXYLIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYJHematoxylinHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647023123PackageGS11In Commercial Distribution
00613647023129PrimaryGS10
10613647023126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702312320613647023123
00613647023129006136470231296136470231290613647023129
1061364702312610613647023126

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
04015630972135Hematoxylin IIVentana Medical Systems, Inc.HYJ2025-12-15
B502BSB03601000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB036010000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360150Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB03602000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360500Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
08435421273498Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
08435804516624Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
00849832027171Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-20
00849832027041Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-19
10849832023064Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
20849832018081Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018087Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00000000000000Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018049Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832020783Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832022817Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00673693089609EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-06
00673693087926EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693087940EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693087964EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693089807EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693089821EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693210126EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483162EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483216EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483223EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483230EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693087971EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693087995EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03