Hematoxylin Solution

Basic Information

• Brand Name: Hematoxylin Solution
• Primary DI: 00850042030158
• Version / Model: 1
• Company Name: Lumatas Biosystems, Inc.
• Labeler DUNS: 080169635
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 1
• Public Version Date: 2023-11-02
• Public Version Status: New
• Public Device Record Key: d60cf1c5-7cdc-428b-9ac8-f176a2fca371

Device Description

Nuclear counterstain

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57782	Immunohistochemistry signal amplification reagent IVD	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850042030141	GS1		2	In Commercial Distribution
Primary	00850042030158	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius