QuikScreen Multi 12 Drug Cup Test

GUDID 20748349000179

QUIKSCREEN Multi 12 Drug Cup Test:AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50

SYNTRON BIORESEARCH, INC.

Drug/toxicology adulteration IVD, kit, enzyme spectrophotometry, rapid

• Primary Device ID: 20748349000179
• NIH Device Record Key: 7dcc454d-7632-4530-8b0a-1a59dbae07bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikScreen Multi 12 Drug Cup Test
• Version Model Number: 60C09
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00748349000175 [Primary]
GS1	10748349000172 [Package]; Contains: 00748349000175; Package: Kit Box [25 Units]; In Commercial Distribution
GS1	20748349000179 [Package]; Contains: 10748349000172; Package: Shipper Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071489

FDA Product Code

• LFH: U.V. Spectrometry, Tricyclic Antidepressant Drugs

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: 2016-10-21

Devices Manufactured by SYNTRON BIORESEARCH, INC.

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• 20748349000049 - QuikSreen 11 Drug Cup Test: 2018-07-06 QuikSreen 11 Drug Cup Test: AMP1000, BAR300, BUP10, BZD300, COC300, MAD300, MDMA500, MET1000, OPI300, OXY100, THC50
• 20748349000056 - QuikScreen 5 Drug Cup Test: 2018-07-06 QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50
• 10748349000066 - QuikStrip MultiDrug 4 Dip Card Test: 2018-07-06 QuikStrip MultiDrug 4 Dip Card: MAD300, OXY 300, OPI300, BZD200