NA

Basic Information

• Brand Name: NA
• Primary DI: 00816576021987
• Version / Model: 295088
• Catalog Number: 295088
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 783e8d6d-924b-4a99-a437-82cee12a058b
• Distribution End Date: 2017-02-08

Device Description

Shigella flexneri Poly B set, 2ml x 9vls

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
GNB	Antisera, All Types, Shigella Spp.	Microbiology	866.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51603	Multiple Shigella species antigen 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 antigens from multiple species of Shigella bacteria in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816576021987	GS1

Customer Contacts

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

Storage Conditions

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