Rapid Response 6 Panel Saliva Test Cup E/I Screening

GUDID 00722066006795

Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.61-2FC1E)- AMP50, COC20, BAR50, OPI40, PCP10, THC40. For employment and insurance testing.

BTNX Inc

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00722066006795
• NIH Device Record Key: fd945f65-a0ac-49f2-9b9c-61ffc2a41634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Response 6 Panel Saliva Test Cup E/I Screening
• Version Model Number: D6.61-2FC1E
• Company DUNS: 251005005
• Company Name: BTNX Inc
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722066006795 [Unit of Use]
GS1	10722066006792 [Primary]

FDA Product Code

• PUX: Test, Amphetamine, Employment And Insurance Testing, Exempt

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: 2023-05-19
• Device Publish Date: 2023-05-11

On-Brand Devices [Rapid Response 6 Panel Saliva Test Cup E/I Screening]

• 00722066006801: Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.64-2FC1E)- AMP50, COC20, MET50, OPI40,
• 00722066006795: Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.61-2FC1E)- AMP50, COC20, BAR50, OPI40,
• 00722066006788: Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.3.1-2FC1E)- AMP50, COC20, MET50, OPI40,