Buprenorphine Enzyme Immunoassay A53684

GUDID 00869335000204

2 x 100 Test Kit. Antibody/Substrate Reagent (R1): 2 x 20 mL. Enzyme Conjugate Reagent (R2): 2 x 5 mL.

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00869335000204
• NIH Device Record Key: d216c075-c8a5-4337-a3c5-56c250ab9d80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Buprenorphine Enzyme Immunoassay
• Version Model Number: A53684
• Catalog Number: A53684
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869335000204 [Primary]

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-07-05

On-Brand Devices [Buprenorphine Enzyme Immunoassay]

• 00869335000204: 2 x 100 Test Kit. Antibody/Substrate Reagent (R1): 2 x 20 mL. Enzyme Conjugate Reagent (R2): 2 x
• 00850624008018: 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.
• B07602710: Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B07602700: Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• 00850624008513: 240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reage