QMS Tacrolimus Immunoassay

Basic Information

• Brand Name: QMS Tacrolimus Immunoassay
• Primary DI: 00884883011830
• Version / Model: 10015556
• Company Name: Microgenics Corporation
• Labeler DUNS: 122153799
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2019-06-05
• Public Version Status: Update
• Public Device Record Key: 99d17d9b-4cac-4cd2-8b5c-1d2ac42bfc79

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
MLM	Enzyme Immunoassay, Tracrolimus	Clinical Chemistry	862.1678	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55445	Tacrolimus therapeutic drug monitoring IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug tacrolimus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884883011830	GS1

Premarket Submissions

Submission Number	Supplement Number
K123343	000