ZYMUTEST HIA MonoStrip IgGAM

Basic Information

• Brand Name: ZYMUTEST HIA MonoStrip IgGAM
• Primary DI: 03663537046810
• Version / Model: RK041D
• Catalog Number: RK041D
• Company Name: HYPHEN BIOMED
• Labeler DUNS: 503499167
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e5f6ee26-f226-4a69-876b-00158677aefc

Device Characteristics

• Single Use: Yes
• 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: 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
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	864.7695	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57307	Polyvalent human immunoglobulin antibody IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of all classes of human immunoglobulin (i.e, IgA, IgE, IgD, IgG, IgM) and/or specific immunoglobulin chains in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03663537046810	GS1

Premarket Submissions

Submission Number	Supplement Number
K071255	000

Storage Conditions

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