Fourteen Panel PreScreen Plus Cup (CLIA Waived)

GUDID 00850557007768

Fourteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: COC | THC | OPI | BZO | MAMP | TCA | OXY | UP | BAR | MTD | AMP | MDMA | PCP | PPX

MERGERS MARKETING, INC.

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

• Primary Device ID: 00850557007768
• NIH Device Record Key: 718ab287-f266-4806-b5ed-04894c92a6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fourteen Panel PreScreen Plus Cup (CLIA Waived)
• Version Model Number: PSC-DOA-1144
• 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	00850557007768 [Primary]
GS1	00850557007775 [Package]; Package: Inner Pack [25 Units]; In Commercial Distribution
GS1	10850557007772 [Package]; Contains: 00850557007775; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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: 2016-07-25

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

• 00850557007782: Fourteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | EDDP |
• 00850557007768: Fourteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: COC | THC | OPI | BZO | MAMP | TCA |