Auto-Lyte 1224UM

GUDID 00608337000085

Auto-Lyte Cotinine Urine 1000mL

Orasure Technologies, Inc.

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00608337000085
• NIH Device Record Key: e0b30848-a79f-44ba-95f8-b53d2fb72fdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auto-Lyte
• Version Model Number: 1224UM
• Catalog Number: 1224UM
• Company DUNS: 114152184
• Company Name: Orasure Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00608337000085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972481

FDA Product Code

• MKU: Enzyme Immunoassasy, Nocotine And Nicotine Metabolites

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-29

On-Brand Devices [Auto-Lyte]

• 00608337000474: Auto-Lyte Cotinine Urine 100mL
• 00608337000085: Auto-Lyte Cotinine Urine 1000mL