FDA.report

Fisherbrand

Primary DI
20613647023116
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
220-100
Catalog number
22220100
Device description
PINNACLE HEMATOXYLIN 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

Related Records

Contact Domains

Product Codes

CodeName
HYJHEMATOXYLIN

Product Code Classifications

CodeDeviceSpecialtyClass
HYJHematoxylinHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20613647023116PackageGS11In Commercial Distribution
00613647023112PrimaryGS10
10613647023119Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702311620613647023116
00613647023112006136470231126136470231120613647023112
1061364702311910613647023119

GMDN Terms

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

Contacts

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

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20613647028340Fisherbrand11002204110022042025-06-30
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20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
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20613647010901FisherbrandSC-150-100135001002025-04-30
20613647010918FisherbrandSC-180-100135001012025-04-30
20613647010925FisherbrandSC-220-100135001022025-04-30
20613647010932FisherbrandSC-250-100135001032025-04-30
20613647018846Fisherbrand23101000231010002025-04-30
20613647018853Fisherbrand23101001231010012025-04-30
20613647018860Fisherbrand23101002231010022025-04-30
20613647018877Fisherbrand23101003231010032025-04-30
20613647018884Fisherbrand23101004231010042025-04-30
20613647018891Fisherbrand23101005231010052025-04-30
20613647024847Fisherbrand19-041-372B19041372B2025-04-30
30613647024851Fisherbrand19-041-372C19041372C2025-04-30
20613647024861Fisherbrand19-041-372D19041372D2025-04-30

Other Devices Sharing Product Codes

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
00849832018049Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832020783Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832022817Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
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