Syva® Emit® d.a.u.® Amphetamine Class Assay

Basic Information

• Brand Name: Syva® Emit® d.a.u.® Amphetamine Class Assay
• Primary DI: 00842768017148
• Version / Model: 10445253
• Catalog Number: 3C019UL
• 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: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: ae9b0ace-c848-41b7-ae4b-09c61fb5e724

Device Description

Syva® Emit ® d.a.u.® Amphetamine Class Assay

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
DKZ	ENZYME IMMUNOASSAY, AMPHETAMINE	Clinical Toxicology	862.3100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55487	Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768017148	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K900995	000

Storage Conditions

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