SAFECUP II MULTIDRUG N5

GUDID 00695684454555

Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, THC, OPI, PCP (cocaine, amphetamine, marijuana, opiates, Phencyclidine).

GERMAINE LABORATORIES, INC

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)

• Primary Device ID: 00695684454555
• NIH Device Record Key: 251b345e-5471-4c5f-a06a-730168116349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFECUP II MULTIDRUG N5
• Version Model Number: 45455
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 25
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684454551 [Unit of Use]
GS1	00695684454555 [Primary]

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: 2016-05-12

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