FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647023673
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
HC12001GL
Catalog number
HC1200
Device description
HISTOPREP 80% ALCOHOL 1GAL
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
PPMGeneral purpose reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647023673PackageGS11In Commercial Distribution
00613647023679PrimaryGS10
10613647023676Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702367320613647023673
00613647023679006136470236796136470236790613647023679
1061364702367610613647023676

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).

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
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891322595CHORUS NEGATIVE CONTROL/SAMPLE DILUENTDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFERDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891328849CHORUS SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
00847627043726NeoPath Background Punisher BIOCARE MEDICAL LLCPPM2026-03-11
04049016151302FITC-labelled anti-human IgA with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
00630414312460Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414312507Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
05407010129847Buffer C_SUO-001_Module L : 1000L BagLonza VerviersPPM2026-02-05
05407010129854Buffer C_SUO-001_Module L : 1L Bag SampLonza VerviersPPM2026-02-05
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)BIOCARE MEDICAL LLCPPM2026-01-29
04049016151340FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
04049016151654FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
05430003908471SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908693SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908631SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908709SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908730LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908785LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908808LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908846LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908860LaCAR Lacar MDX TechnologiesPPM2026-01-15
08435804522199FISH PT KITVITRO SAPPM2026-01-15
08435804522212DEWAX-2 FISHVITRO SAPPM2026-01-15
08435804522366FISH PT KITVITRO SAPPM2026-01-15
08435804522397DEWAX-2 FISH VITRO SAPPM2026-01-15