AIMSTEP COTININE

GUDID 00695684400156

Cassette test for nicotine

GERMAINE LABORATORIES, INC

Cotinine (nicotine metabolite) IVD, reagent

• Primary Device ID: 00695684400156
• NIH Device Record Key: c9fed968-4eb7-4ea4-8990-e84272259021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIMSTEP COTININE
• Version Model Number: 40015
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684400121 [Unit of Use]
GS1	00695684400156 [Primary]

FDA Product Code

• MRS: Test System, Nicotine, Cotinine, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-12

On-Brand Devices [AIMSTEP COTININE]

• 00695684400156: Cassette test for nicotine
• 00695684400125: Cassette test for nicotine
• 00695684400101: Cassette test for nicotine