HYTEC Cow Dander

Basic Information

• Brand Name: HYTEC Cow Dander
• Primary DI: 00816879022353
• Version / Model: E004
• Catalog Number: 74220
• Company Name: HYCOR BIOMEDICAL LLC
• Labeler DUNS: 010558476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-28
• Public Version: 1
• Public Version Date: 2020-08-05
• Public Version Status: New
• Public Device Record Key: b03a09e1-154d-48a6-a3be-e6948dc6ee8a

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53791	Immunoglobulin G subclass (IgG subclass) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816879022353	GS1

Customer Contacts

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

Storage Conditions

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