FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647023754
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
HC7001GAL
Catalog number
HC7001GAL
Device description
HISTOPREP XYLENES 1GAL
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
KEMAGENT, CLEARING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEMAgent, ClearingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647023758PackageGS11In Commercial Distribution
00613647023754PrimaryGS10
10613647023751Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702375820613647023758
00613647023754006136470237546136470237540613647023754
1061364702375110613647023751

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue processing reagent kit IVDA collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fixative (e.g., formalin), a dehydrating agent (e.g., alcohol) and a clearing reagent (e.g., xylene).

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
50885380043268CARDINAL HEALTHCardinal Health 200, LLCKEM2026-01-06
10885380043260CARDINAL HEALTHCardinal Health 200, LLCKEM2026-01-06
00613647028438FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028506FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028513FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028636FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028432FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028500FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028517FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028630FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00673693086974EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693087032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693088923EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101561EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101592EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101608EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693228374EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236102EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236133EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236140EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693476126EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693556736EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755078EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755085EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755115EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693087025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-22
00673693476133EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-22
00810047420583N/AScientific Device Laboratory, Inc.KEM2023-01-31
00810047420989N/AScientific Device Laboratory, Inc.KEM2023-01-31
00810047420996N/AScientific Device Laboratory, Inc.KEM2023-01-31