00840050508268

GUDID 00840050508268

AMERICAN SCREENING, L.L.C.

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

• Primary Device ID: 00840050508268
• NIH Device Record Key: a32c7766-7cf1-4f86-a232-e6e3f894b525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 00840050508268
• Version Model Number: DISP-DOA434NPT
• Company DUNS: 169065054
• Company Name: AMERICAN SCREENING, L.L.C.
• 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: 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	00840050508268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180349

FDA Product Code

• NGG: Test, Methamphetamine, Over The Counter

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: 2022-11-21
• Device Publish Date: 2022-11-11

Devices Manufactured by AMERICAN SCREENING, L.L.C.

• 00840050500170 - OneScreen: 2022-11-21
• 00840050500187 - OneScreen: 2022-11-21
• 00840050500194 - OneScreen: 2022-11-21
• 00840050500200 - OneScreen: 2022-11-21
• 00840050500217 - OneScreen: 2022-11-21
• 00840050500224 - OneScreen: 2022-11-21
• 00840050500231 - OneScreen: 2022-11-21
• 00840050500248 - OneScreen: 2022-11-21