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

• 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

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

• B07605700 - Fentanyl II Enzyme Immunoassay: 2022-08-01 Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• B07605710 - Fentanyl II Enzyme Immunoassay: 2022-08-01 Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B07604100 - LZI Tramadol Enzyme Immunoassay: 2022-05-09 Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• B07604110 - LZI Tramadol Enzyme Immunoassay: 2022-05-09 Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B07604120 - LZI Tramadol Low Calibrator: 2022-05-09 5 mL/bottle. Concentration: 50 ng/mL of Tramadol.
• B07604130 - LZI Tramadol Cutoff Calibrator: 2022-05-09 5 mL/bottle. Concentration: 100 ng/mL of Tramadol.
• B07604140 - LZI Tramadol Intermediate Calibrator: 2022-05-09 5 mL/bottle. Concentration: 225 ng/mL of Tramadol.
• B07604150 - LZI Tramadol High Calibrator: 2022-05-09 5 mL/bottle. Concentration: 400 ng/mL of Tramadol.