FDA.reportPublic FDA data

Hematoxylin Solution

Primary DI
00850042030141
Brand
Hematoxylin Solution
Company
Lumatas Biosystems, Inc.
Model
1
Device description
Nuclear counterstain
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
00850042030141PackageGS12In Commercial Distribution
00850042030158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042030141008500420301418500420301410850042030141
00850042030158008500420301588500420301580850042030158

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry signal amplification reagent IVDA substance or reactant intended to be used for signal amplification and enhancement of staining when testing biological tissues or clinical specimens using an immunohistochemistry assay.

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405000166Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000173Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000180Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000678Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000685Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000692Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000760Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000777Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000784Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000791Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000807Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000814Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001156Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001163Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001170Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001187Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001194Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001200Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001309Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001316Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001323Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001453Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001460Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001477Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001811Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001828Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001835Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001842Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001859Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001866Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09