Fentanyl II Enzyme Immunoassay 10427531190

GUDID 00850624008643

850 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 63.3 mL Enzyme Conjugate Reagent (R2): 1 x 26.9 mL

LIN-ZHI INTERNATIONAL, INC.

Fentanyl IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850624008643
• NIH Device Record Key: 6240a80e-5a33-4950-a123-55603611a6ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fentanyl II Enzyme Immunoassay
• Version Model Number: 10427531190
• Catalog Number: 10427531190
• 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: true
• 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
GS1	00850624008643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201938

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: 2025-11-25
• Device Publish Date: 2025-11-17

On-Brand Devices [Fentanyl II Enzyme Immunoassay]

• 00850624008254: 200 tests. c 501/502, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reagent
• 00850624008261: 240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reage
• B07605710: Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B07605700: Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
• 00850624008643: 850 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 63.3 mL Enzyme Conjugate Reage