Chlamydia Antigen Substrate, 12 wells, For IFA Test System

Basic Information

• Brand Name: Chlamydia Antigen Substrate, 12 wells, For IFA Test System
• Primary DI: B110CH41120
• Version / Model: CH-4112
• Catalog Number: CH-4112
• Company Name: Bion Enterprises, Ltd.
• Labeler DUNS: 024824641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: e3b4a928-f6b3-4f02-abcf-9ceb913d170c

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: 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
LKI	Antisera, Fluorescent, Chlamydia Spp.	Microbiology	866.3120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50726	Multiple Chlamydia species total antibody 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 total antibodies to one or multiple species of Chlamydia bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B110CH41120	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K894625	000

Storage Conditions

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