IMMCO DIAGNOSTICS

Basic Information

• Brand Name: IMMCO DIAGNOSTICS
• Primary DI: 00845714004353
• Version / Model: 2308
• Catalog Number: 2308
• Company Name: IMMCO DIAGNOSTICS, INC.
• Labeler DUNS: 079935300
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-01-03
• Public Version Status: Update
• Public Device Record Key: 206bb491-b2ac-4a00-a8a0-40ddc6d7e3d5

Device Description

Serum Diluent

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	866.5660	2
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845714004353	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			60 ml

Storage Conditions

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