QuikScreen 4 Drug Cup

GUDID 20748349000209

QuikScreen 4 Drug Cup - AMP 1000, COC 300, OPI 2000,THC 50

SYNTRON BIORESEARCH, INC.

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

• Primary Device ID: 20748349000209
• NIH Device Record Key: a9a5552a-e45b-4a09-9b39-c4a85668d7bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikScreen 4 Drug Cup
• Version Model Number: 60400
• 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	00748349000205 [Primary]
GS1	10748349000202 [Package]; Contains: 00748349000205; Package: Kit Box [25 Units]; In Commercial Distribution
GS1	20748349000209 [Package]; Contains: 00748349000205; 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: 2016-11-11

Devices Manufactured by SYNTRON BIORESEARCH, INC.

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