Discover

GUDID 00840050503904

AMERICAN SCREENING, L.L.C.

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

• Primary Device ID: 00840050503904
• NIH Device Record Key: 30f0ced9-c9e3-45df-b8b1-7ab15a00345b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discover
• Version Model Number: DIS-CUP-274
• 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	00840050503904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180349

FDA Product Code

• NFY: Test, Cocaine And Cocaine Metabolites, 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

On-Brand Devices [Discover]

• 00840050510544: DIS-VACU-CUP
• 00840050510537: DIS-VACU-CUP
• 00840050510520: DIS-VACU7TUBE
• 00840050510513: DIS-VACU7TUBE
• 00840050510506: DIS-SAL-964
• 00840050510490: DIS-SAL-964
• 00840050510483: DIS-SAL-3114A
• 00840050510476: DIS-SAL-3114A
• 00840050510469: DIS-SAL-254
• 00840050510452: DIS-SAL-254
• 00840050510445: DIS-SAL-17104
• 00840050510438: DIS-SAL-17104
• 00840050510421: DIS-SAL-164
• 00840050510414: DIS-SAL-164
• 00840050510407: DIS-SAL-1104A
• 00840050510391: DIS-SAL-1104A
• 00840050506004: DIS-MTHP-114
• 00840050505991: DIS-MTHP-114
• 00840050505984: DIS-MDPV-101
• 00840050505977: DIS-MDPV-101
• 00840050505960: DIS-KDUD-374
• 00840050505953: DIS-KDUD-374
• 00840050505946: DIS-KDUD-3104
• 00840050505939: DIS-KDUD-3104
• 00840050505922: DIS-KDUD-264
• 00840050505915: DIS-KDUD-264
• 00840050505908: DIS-KDUD-2124
• 00840050505892: DIS-KDUD-2124
• 00840050505885: DIS-KDUD-154
• 00840050505878: DIS-KDUD-154
• 00840050505861: DIS-KDUD-1104
• 00840050505854: DIS-KDUD-1104
• 00840050505847: DIS-KCUP-454
• 00840050505830: DIS-KCUP-454
• 00840050505823: DIS-KCUP-374
• 00840050505816: DIS-KCUP-374
• 00840050505809: DIS-KCUP-264
• 00840050505793: DIS-KCUP-264
• 00840050505786: DIS-KCUP-254
• 00840050505779: DIS-KCUP-254
• 00840050505762: DIS-KCUP-2124
• 00840050505755: DIS-KCUP-2124
• 00840050505748: DIS-KCUP-154
• 00840050505731: DIS-KCUP-154
• 00840050505724: DIS-KCUP-1104
• 00840050505717: DIS-KCUP-1104
• 00840050505700: DIS-ETG300-114
• 00840050505694: DIS-ETG300-114
• 00840050505687: DIS-ETG-114
• 00840050505670: DIS-ETG-114