LZI Cotinine II Level 2 Control 0528

GUDID B07605280

5 mL/bottle. Concentration: 250 ng/mL of Cotinine.

LIN-ZHI INTERNATIONAL, INC.

Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control Cotinine (nicotine metabolite) IVD, control

• Primary Device ID: B07605280
• NIH Device Record Key: 4b9b183d-e73c-4c38-9a9b-574f042d4e29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LZI Cotinine II Level 2 Control
• Version Model Number: 0528
• Catalog Number: 0528
• Company DUNS: 840839190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• 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: true
• OTC Over-The-Counter: false

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
• 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
• 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
• 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
• 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
HIBCC	B07605280 [Primary]

FDA Product Code

• LAS: Drug Specific Control Materials

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: 2022-05-02
• Device Publish Date: 2022-04-22

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