Salimetrics 1-2112-5

GUDID 00859410006092

High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit (5-pack)

SALIMETRICS, LLC

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

• Primary Device ID: 00859410006092
• NIH Device Record Key: 7fe347bb-b9f1-493d-95aa-b64de54cb7cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salimetrics
• Version Model Number: N/A
• Catalog Number: 1-2112-5
• Company DUNS: 084843064
• Company Name: SALIMETRICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859410006092 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-14

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