Auto-Lyte

Basic Information

• Brand Name: Auto-Lyte
• Primary DI: 00608337000085
• Version / Model: 1224UM
• Catalog Number: 1224UM
• Company Name: Orasure Technologies, Inc.
• Labeler DUNS: 114152184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e0b30848-a79f-44ba-95f8-b53d2fb72fdd

Device Description

Auto-Lyte Cotinine Urine 1000mL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
MKU	Enzyme Immunoassasy, Nocotine And Nicotine Metabolites	Clinical Toxicology	862.3220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55579	Cotinine (nicotine metabolite) 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 cotinine (nicotine metabolite) 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	00608337000085	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K972481	000

Storage Conditions

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