Mast Assure

Basic Information

• Brand Name: Mast Assure
• Primary DI: 15060392377816
• Version / Model: M10129
• Catalog Number: M10129
• Company Name: MAST GROUP LIMITED
• Labeler DUNS: 212623821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-02
• Public Version: 1
• Public Version Date: 2018-06-04
• Public Version Status: New
• Public Device Record Key: b90ffd7e-81f2-41e7-9e8a-d29e27e206f9

Device Description

Shigella flexneri Type IV Antiserum

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
51632	Shigella flexneri culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Shigella flexneri bacteria isolated by culture from a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060392377816	GS1

Storage Conditions

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