Fentanyl II Enzyme Immunoassay 0570

GUDID B07605700

Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.

LIN-ZHI INTERNATIONAL, INC.

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

• Primary Device ID: B07605700
• NIH Device Record Key: 34b44649-a65f-4747-8adf-e91bbc2fae0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fentanyl II Enzyme Immunoassay
• Version Model Number: 0570
• Catalog Number: 0570
• 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	B07605700 [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: 2022-08-01
• Device Publish Date: 2022-07-22

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.