Accutest MultiDrug Test Cup 6+3 w. Adulteration Screen

GUDID 10763924908636

MultiDrug Test Cup 6+3 w. Adulteration Screen (pH/ S.G./ Oxidant) (AMP1000 /COC 300 /MET 1000/ OPI 2000/ PCP 25/ THC 50)

JANT PHARMACAL CORPORATION

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

• Primary Device ID: 10763924908636
• NIH Device Record Key: cd41092e-cbfd-4181-8615-3cd1751a6175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest MultiDrug Test Cup 6+3 w. Adulteration Screen
• Version Model Number: DS908
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763924908639 [Unit of Use]
GS1	10763924908636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-24

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