FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647028346
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
11002204
Catalog number
11002204
Device description
PROTOCOL DECALCIFYN SOL B 32OZ
Published
2025-06-30
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
KDXSOLUTION, DECALCIFIER, ACID CONTAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDXSolution, Decalcifier, Acid ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647028340PackageGS11In Commercial Distribution
00613647028346PrimaryGS10
10613647028343Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702834020613647028340
00613647028346006136470283466136470283460613647028346
1061364702834310613647028343

GMDN Terms#

Term, Definition table
TermDefinition
Decalcifying solution IVDA solution intended to be used as a decalcifying agent in the processing of clinical specimens and biological tissues for subsequent in vitro diagnostic analysis. It is typically in the form of an inorganic acid [e.g., hydrochloric acid (HCl)], organic acid [e.g., formic acid (CH2O2)] or a chelating agent [e.g., ethylenediaminetetraacetic acid (EDTA)].

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-1500regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
4
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00613647018880Fisherbrand23101004231010042025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20613647028340FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDX2025-06-30
00673693078917EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693089050EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693089067EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693228251EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693228268EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693228275EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693228282EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26