Methadone Metabolite Enzyme Immunoassay 0191b

GUDID B0760191B0

Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.

LIN-ZHI INTERNATIONAL, INC.

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B0760191B0
• NIH Device Record Key: 098c94f0-81ab-4a89-8679-5fe51486e20d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Methadone Metabolite Enzyme Immunoassay
• Version Model Number: 0191b
• Catalog Number: 0191b
• Company DUNS: 840839190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0760191B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170416

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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: 2019-10-28
• Device Publish Date: 2018-09-17

On-Brand Devices [Methadone Metabolite Enzyme Immunoassay]

• 00850624008179: 200 tests. Antibody/Substrate Reagent (R1): 1 x 21.58 mL Enzyme Conjugate Reagent (R2): 1 x 9.8
• B0760191B0: Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B07601910: Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B0760190B0: Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• B07601900: Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• 00850624008247: 240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reage