Emit® 2000 Theophylline Assay

Basic Information

• Brand Name: Emit® 2000 Theophylline Assay
• Primary DI: 00842768023286
• Version / Model: 10445326
• Catalog Number: 4P229
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 1f00ff1d-2bc9-45c0-b82b-317c01102e73

Device Description

Emit® 2000 Theophylline Assay labeled with the Beckman Coulter® name

Device Characteristics

• Single Use: No
• 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
KLS	ENZYME IMMUNOASSAY, THEOPHYLLINE	Clinical Toxicology	862.3880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59056	Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the anti-asthma drug theophylline in a clinical specimen, using and enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768023286	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011166	000

Storage Conditions

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