Cocaine OraSure 5 Plate Kit

GUDID 00608337000412

Orasure Technologies, Inc.

Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

• Primary Device ID: 00608337000412
• NIH Device Record Key: eb22d26a-83c2-4c3e-918e-3201ec30dbb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cocaine OraSure 5 Plate Kit
• Version Model Number: 1122SB
• Company DUNS: 114152184
• Company Name: Orasure Technologies, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00608337000412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982061

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine 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: 2016-09-12

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