ImmunoFA Toxoplasma IgM Positive Control

Basic Information

• Brand Name: ImmunoFA Toxoplasma IgM Positive Control
• Primary DI: 00613745013411
• Version / Model: 800-1341
• Catalog Number: 1341
• Company Name: Genbio
• Labeler DUNS: 940425333
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 859bd0dc-f8b1-423b-a615-693644c7f568

Device Description

Positive control for use with ImmunoFA Toxoplasma IgM kit.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
GLZ	Antigens, If, Toxoplasma Gondii	Microbiology	866.3780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42164	Toxoplasma gondii 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 the parasitic protozoan Toxoplasma gondii in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613745013411	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K803134	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.0 mL

Storage Conditions

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