Quikscreen

GUDID 20748349000339

QSCREEN 4 Multi Test - COC 300, MET 1000, OPI 2000,THC 50

SYNTRON BIORESEARCH, INC.

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• Primary Device ID: 20748349000339
• NIH Device Record Key: 28357ac1-cc53-4b47-8500-df421dc26ff0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quikscreen
• Version Model Number: 60411
• Company DUNS: 174517060
• Company Name: SYNTRON BIORESEARCH, INC.
• 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	00748349000335 [Primary]
GS1	10748349000332 [Package]; Contains: 00748349000335; Package: Inner Pack [25 Units]; In Commercial Distribution
GS1	20748349000339 [Package]; Contains: 10748349000332; Package: Shipper Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071489

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-01

On-Brand Devices [Quikscreen]

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• 20748349000292: QUIKSCREEN MULTI 6+1 DRUG CUP TEST - AMP 1000, BZD 300, COC 300, MET 1000, OPI 300, THC 50 + ALC
• 20748349000285: QUIKSCREEN MULTI 5 DRUG CUP TEST - BZD 300, COC 300, MET 1000, OPI 300, THC 50
• 20748349000278: QUIKSCREEN MULTI 12 DRUG CUP TEST - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MDMA 500, MET
• 20748349000247: QuikScreen Multi 10 Drug Cup Test - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MET 1000, OPI
• 20748349000223: QuikScreen Multi 9+1 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, MET 1000, OPI
• 20748349000193: QUIKSCREEN MULTI 11 DRUG CUP TEST - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MDMA 500, MET
• 10748349000165: QuikScreen Multi 8 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, OPI 300, OXY 100
• 20748349000155: QuikScreen Multi 12+3 Drug Cup Test - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA
• 00748349000144: QuikScreen Multi 8+5 Drug Cup Test - AMP 500, BUP 10, COC 300, MAD 300, MDMA 500, MET 500, OPI
• 20748349000131: QuikScreen Multi 7 Drug Cup Test - AMP 500, MDMA 500, COC 300, MET 500, OPI 300, MAD 300, THC 5
• 20748349000117: QuikScreen Multi 5 Drug Cup Test - AMP 1000, BZD 300, COC 300, OPI 2000, THC 50