Mycoplasma pneumoniae IgM Control

Basic Information

• Brand Name: Mycoplasma pneumoniae IgM Control
• Primary DI: B110MPM12300
• Version / Model: MPM-1230
• Catalog Number: MPM-1230
• 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: 3
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: ffd48e16-5643-4c8f-ae17-c0a347ad9fe6

Device Characteristics

• Single Use: No
• 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: 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
LQG	Dna-Reagents, Mycoplasma Spp.	Microbiology	866.3375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51205	Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B110MPM12300	HIBCC

Customer Contacts

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

Storage Conditions

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