FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647028340
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
Rx
false
OTC
false
Sterile
false
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)].

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00613647028346FisherbrandFISHER 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