Ten Panel PreScreen Plus Cup (CLIA Waived)

GUDID 00850557007669

Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP

MERGERS MARKETING, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00850557007669
• NIH Device Record Key: 6cac1f74-e017-4a19-8789-aff66451eeaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ten Panel PreScreen Plus Cup (CLIA Waived)
• Version Model Number: PSC-DOA-8104
• Company DUNS: 065602744
• Company Name: MERGERS MARKETING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00850557007669 [Primary]
GS1	00850557007676 [Package]; Package: Inner Pack [25 Units]; In Commercial Distribution
GS1	10850557007673 [Package]; Contains: 00850557007676; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-26

On-Brand Devices [Ten Panel PreScreen Plus Cup (CLIA Waived)]

• 00850557007669: Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD
• 00850557007621: Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BAR | BUP | BZO | COC | MET | MTD | OPI |
• 00850557007584: Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI |
• 00850557007508: Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD