FDA.reportPublic FDA data

Deparaffinization Solution

Primary DI
00850042030028
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
Rx
false
OTC
false
Sterile
false
Single use
false

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080169635
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810202560406goldFISHDF0102025-11-18
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00810202560420goldFISHDF0122025-11-18
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00810202560451goldFISHDF0242025-11-18
00810202560468goldFISHDF0282025-11-18
00810202560475goldFISHDF0292025-11-18
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00810202560499goldFISHDF0312025-11-18
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00810202560512goldFISHDF0332025-11-18
00810202560529goldFISHDF0482025-11-18
00810202560536goldFISHDF0492025-11-18
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00810202560550goldFISHDF0532025-11-18
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00810202560574goldFISHDF0562025-11-18
00810202560581goldFISHDF0612025-11-18
00810202560598goldFISHDF0632025-11-18

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