Oral Fluid Amphetamine Enzyme Immunoassay S0041b

GUDID B076S0041B0

Large Test Kit. Antibody/Substrate Reagent (R1): 750 mL. Enzyme Conjugate Reagent (R2): 375 mL.

LIN-ZHI INTERNATIONAL, INC.

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA) Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B076S0041B0
• NIH Device Record Key: fa59b3b7-9dd0-4704-b1c7-007379206897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral Fluid Amphetamine Enzyme Immunoassay
• Version Model Number: S0041b
• Catalog Number: S0041b
• 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	B076S0041B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131653

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2016-07-05

On-Brand Devices [Oral Fluid Amphetamine Enzyme Immunoassay]

• B076S0041B0: Large Test Kit. Antibody/Substrate Reagent (R1): 750 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B076S0040B0: Small Test Kit. Antibody/Substrate Reagent (R1): 75 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.