VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit

Basic Information

• Brand Name: VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit
• Primary DI: 05051700006767
• Version / Model: MK016
• Company Name: THE BINDING SITE GROUP LIMITED
• Labeler DUNS: 347045614
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: bd653800-1554-465e-a91e-c02e04ed75c4

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: 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
GRP	Antisera, All Types, H. Influenza	Microbiology	866.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50975	Haemophilus influenzae culture isolate antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from one or multiple strains of Haemophilus influenzae bacteria isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051700006767	GS1

Customer Contacts

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

Storage Conditions

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