FDA.reportPublic FDA data

Deparaffinization Solution

Primary DI
00850042030035
Brand
Deparaffinization Solution
Company
Lumatas Biosystems, Inc.
Model
1
Device description
Removes the paraffin from formalin fixed, paraffin embedded tissue sections
Published
2023-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042030028PackageGS12In Commercial Distribution
00850042030035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042030028008500420300288500420300280850042030028
00850042030035008500420300358500420300350850042030035

GMDN Terms#

Term, Definition table
TermDefinition
Dewaxing solution IVDA substance intended to be used to remove paraffin wax from formalin-fixed, paraffin-embedded biological tissues or clinical specimens for subsequent in vitro diagnostic (IVD) testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
080169635
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810202560406goldFISHDF0102025-11-18
00810202560413goldFISHDF0112025-11-18
00810202560420goldFISHDF0122025-11-18
00810202560437goldFISHDF0222025-11-18
00810202560444goldFISHDF0232025-11-18
00810202560451goldFISHDF0242025-11-18
00810202560468goldFISHDF0282025-11-18
00810202560475goldFISHDF0292025-11-18
00810202560482goldFISHDF0302025-11-18
00810202560499goldFISHDF0312025-11-18
00810202560505goldFISHDF0322025-11-18
00810202560512goldFISHDF0332025-11-18
00810202560529goldFISHDF0482025-11-18
00810202560536goldFISHDF0492025-11-18
00810202560543goldFISHDF0522025-11-18
00810202560550goldFISHDF0532025-11-18
00810202560567goldFISHDF0542025-11-18
00810202560574goldFISHDF0562025-11-18
00810202560581goldFISHDF0612025-11-18
00810202560598goldFISHDF0632025-11-18

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