BD Difco™ QC Antigen Shigella Group A

Basic Information

• Brand Name: BD Difco™ QC Antigen Shigella Group A
• Primary DI: 00382902210016
• Version / Model: 221001
• Catalog Number: 221001
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-28
• Public Version: 3
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: eb809b80-1c40-43db-b531-1a5b37e64978
• Distribution End Date: 2016-11-29

Device Description

Vial Qc Antigen Shigella Grp A 1Ml

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
LIA	ANTIGENS, ALL GROUPS, SHIGELLA SPP.	Microbiology	866.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51602	Multiple Shigella species culture isolate antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from one or multiple species of Shigella 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	00382902210016	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

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