ACCUTEST - 5 Drug Test Cup *CLIA-Waived*

GUDID 10763924086532

ACCUTEST - 5 Drug Test Cup *CLIA-Waived* AMP (1000), COC (300), OPI (2000), PCP (25), and THC (50)

JANT PHARMACAL CORPORATION

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• Primary Device ID: 10763924086532
• NIH Device Record Key: bf31ff2a-fafa-44a9-a028-ba6de36ad59c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUTEST - 5 Drug Test Cup *CLIA-Waived*
• Version Model Number: DS86S625
• 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: true
• 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	00763924086535 [Unit of Use]
GS1	10763924086532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071489

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: 4
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-23

Devices Manufactured by JANT PHARMACAL CORPORATION

• 10763924851109 - Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived): 2023-07-06 Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived)
• 10763924853202 - Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived): 2023-07-06 Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived)
• 10763924864208 - Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine): 2023-07-06 Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine)
• 10763924095213 - Accutest Breath Alcohol Detector: 2022-11-28 Breath Alcohol Detector, .02 % BAC.
• 10763924097224 - Accustrip Saliva Alcohol Test: 2022-11-28 Saliva Alcohol Test Strip
• 10763924210142 - Accutest: 2022-11-28 2 Parameter Urine Reagent Strip (Glucose, Protein)
• 10763924410146 - Accutest: 2022-11-28 4-Parameter Urine Reagent Strip (Glucose, Protein, Nitrite, Leukocytes
• 10763924601568 - ACCUTEST Uriscreen Rapid Screen for UTI. Test: 2022-11-28 Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine.