ImmuKnow

Basic Information

• Brand Name: ImmuKnow
• Primary DI: 00863651000306
• Version / Model: 4400
• Company Name: VIRACOR-IBT LABORATORIES, INC.
• Labeler DUNS: 125886114
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 771dbdec-2344-4543-bfd6-1be0a179e6bf

Device Description

Immune cell function assay kit.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
NID	Assay, Proliferation, In Vitro, T Lymphocyte	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57630	T lymphocyte IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of T lymphocytes in a clinical specimen, using an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863651000306	GS1

Customer Contacts

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

Storage Conditions

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