Quick Test

GUDID 20863451000425

Individual 10-panel drug test cassette

QUICKCO, LTD

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid

• 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