LZI Oxycodone III Enzyme Immunoassay 0611

GUDID B07606110

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

LIN-ZHI INTERNATIONAL, INC.

Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B07606110
• NIH Device Record Key: ab9b89ef-fdf7-47fd-93f4-51e14d2312ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LZI Oxycodone III Enzyme Immunoassay
• Version Model Number: 0611
• Catalog Number: 0611
• 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
• 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	B07606110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202007

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2021-08-26
• Device Publish Date: 2021-08-18

On-Brand Devices [LZI Oxycodone III Enzyme Immunoassay]

• B07606110: Large Test Kit Antibody/Substrate Reagent (R1): 1000 mL Enzyme Conjugate Reagent (R2): 375 mL
• B07606100: Small Test Kit Antibody/Substrate Reagent (R1): 100 mL Enzyme Conjugate Reagent (R2): 37.5 mL