Salimetrics 1-2112

GUDID 00859410006108

High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit

SALIMETRICS, LLC

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

• Primary Device ID: 00859410006108
• NIH Device Record Key: 7cff986c-71d8-4769-bf6b-f3ef014a2131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salimetrics
• Version Model Number: N/A
• Catalog Number: 1-2112
• 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	00859410006108 [Primary]

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: 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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• 00859410006108: High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit
• 00859410006092: High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit (5-pack)
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• 00859410006054: Salivary Progesterone Enzyme Immunoassay Kit (5-pack)
• 00859410006047: Salivary Progesterone Enzyme Immunoassay Kit
• 00859410006030: Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit
• 00859410006023: Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (25 pack)
• 00859410006016: Expanded Range High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit (5-pack)
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• 00859410006153: High Sensitivity Salivary Estriol Enzyme Immunoassay Kit
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• 00859410006245: Expanded Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit (5-pack)
• 00859410006276: Salivary Insulin Elisa Kit (5-pack)
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• 00859410006306: Salimetrics Cryovial, Blue 25/pk
• 00859410006290: Salimetrics Cryovial, Red 25/pk
• 00859410006283: Salimetrics Cryovial, White 25/pk