Immunalysis Corporation

Basic Information

• Brand Name: Immunalysis Corporation
• Primary DI: 00840937110140
• Version / Model: GPR-A-186-100
• Company Name: IMMUNALYSIS CORPORATION
• Labeler DUNS: 080589004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-25
• Public Version: 5
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: d5224c31-aa29-4755-a98e-6d3c549e6187

Device Description

Immunalysis Corporation Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57769	Immunohistochemistry antibody diluent IVD	A substance or reactant intended to be used for the dilution of antibody solution for use in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840937110140	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius