Accutest 12 MultiDrug Test Cup

GUDID 10763924930637

MultiDrug Test Cup 12; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC

JANT PHARMACAL CORPORATION

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

• Primary Device ID: 10763924930637
• NIH Device Record Key: 5341f0c4-8ff7-4eb4-b15b-0f4c6de39722
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest 12 MultiDrug Test Cup
• Version Model Number: DS930
• 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	00763924930630 [Unit of Use]
GS1	10763924930637 [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

On-Brand Devices [Accutest 12 MultiDrug Test Cup]

• 10763924932631: MultiDrug Test Cup 12; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA, THC
• 10763924930637: MultiDrug Test Cup 12; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC