QuikScreen Multi 11 Drug Cup Test

GUDID 10748349000103

QuikScreen Multi 11 Drug Cup Test - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 300, OXY 100, TCA 1000, THC 50

SYNTRON BIORESEARCH, INC.

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

• Primary Device ID: 10748349000103
• NIH Device Record Key: 05fe406c-f72e-4239-a2ad-d05b83bde984
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikScreen Multi 11 Drug Cup Test
• Version Model Number: 60B00
• 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	00748349000106 [Primary]
GS1	10748349000103 [Package]; Contains: 00748349000106; Package: Kit Box [25 Units]; In Commercial Distribution
GS1	20748349000100 [Package]; Package: Shipper Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071489

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2016-10-04

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
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• 10748349000066 - QuikStrip MultiDrug 4 Dip Card Test: 2018-07-06 QuikStrip MultiDrug 4 Dip Card: MAD300, OXY 300, OPI300, BZD200