Mast Assure Escherichia coli O26 antiserum

Basic Information

• Brand Name: Mast Assure Escherichia coli O26 antiserum
• Primary DI: 15060392376253
• Version / Model: M12014
• Catalog Number: M12014
• Company Name: MAST GROUP LIMITED
• Labeler DUNS: 212623821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-17
• Public Version: 1
• Public Version Date: 2018-09-17
• Public Version Status: New
• Public Device Record Key: a7c386e2-2a7d-4a0f-9a7c-442e8389e73d

Device Description

M12014 - Escherichia coli Monovalent O Antiserum - Factor O26 - 2ml

Device Characteristics

• Single Use: Yes
• 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
GNA	Antisera, All Types, Escherichia Coli	Microbiology	866.3255	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62451	Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from multiple strains of Escherichia coli (E. coli) bacteria [e.g., O86: K61, O114: K90, O125: K70, O127: K63, O128: K67, O44: K74, O112: K66, O124: K72, O142: K86] isolated by culture from a clinical specimen, using an agglutination method.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060392376253	GS1

Storage Conditions

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