QuikScreen 13+4 Drug Cup Test

GUDID 20748349000032

QuikScreen 13+4 (pouch cup): AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, MDMA 500, OPI 300, OXY 100, PCP 25, THC 50 + pH/CRE/SG/GTA

SYNTRON BIORESEARCH, INC.

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

• Primary Device ID: 20748349000032
• NIH Device Record Key: 84c7f027-09b0-42ae-b03f-72a5f243f40e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikScreen 13+4 Drug Cup Test
• Version Model Number: 65D03-17
• 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	00748349000038 [Primary]
GS1	10748349000035 [Package]; Contains: 00748349000038; Package: Kit Box [25 Units]; In Commercial Distribution
GS1	20748349000032 [Package]; Contains: 10748349000035; Package: Shipper Box [4 Units]; In Commercial Distribution

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-27

Devices Manufactured by SYNTRON BIORESEARCH, INC.

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