Quick Test

GUDID 20863451000425

Individual 10-panel drug test cassette

QUICKCO, LTD

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

• Primary Device ID: 20863451000425
• NIH Device Record Key: 05b70596-6a1d-486d-9779-a2b9909938bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick Test
• Version Model Number: 1.0
• Company DUNS: 080767145
• Company Name: QUICKCO, LTD
• 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	00850349008034 [Package]; Contains: 10863451000428; Package: Product Package [1 Units]; In Commercial Distribution
GS1	00863451000421 [Package]; Contains: 10863451000428; Package: Display Carton [2 Units]; In Commercial Distribution
GS1	10863451000428 [Primary]
GS1	20863451000425 [Package]; Contains: 00863451000421; Package: Shipper Display Tray [6 Units]; In Commercial Distribution
GS1	30863451000422 [Package]; Contains: 10863451000428; Package: Middle Pack Shipper [100 Units]; In Commercial Distribution
GS1	40863451000429 [Package]; Contains: 10863451000428; Package: Master Case Import [1200 Units]; In Commercial Distribution
GS1	50863451000426 [Package]; Contains: 10863451000428; Package: Master Carton [72 Units]; In Commercial Distribution
GS1	60863451000423 [Package]; Contains: 10863451000428; Package: Master Carton [72 Units]; In Commercial Distribution
GS1	70863451000420 [Package]; Contains: 10863451000428; Package: Shipper Display [6 Units]; In Commercial Distribution
GS1	80863451000427 [Package]; Contains: 10863451000428; Package: Shipper display [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-05-24
• Device Publish Date: 2018-02-22