Accutest DS84S625

GUDID 10763924084651

Drug Test Cup 5+3 for visual qualitative detection of THC, COC, AMP, MET, OPI2000 with OX, SG, pH adulterant tests

JANT PHARMACAL CORPORATION

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• Primary Device ID: 10763924084651
• NIH Device Record Key: fee9cc63-5f22-451f-88cb-affd09491403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest
• Version Model Number: DS84S625
• Catalog Number: DS84S625
• 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: true

Customer Support Contacts

• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net
• Phone: 1-800-676-5565
• Email: info@accutest.net

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763924084654 [Unit of Use]
GS1	10763924084651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082898

FDA Product Code

• NGL: Test, Opiates, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-24

On-Brand Devices [Accutest ]

• 10763924935632: Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO and OPI300
• 10763924093639: Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO, OPI300 (CLIA Waived)
• 10763924084651: Drug Test Cup 5+3 for visual qualitative detection of THC, COC, AMP, MET, OPI2000 with OX, SG, p
• 10763924710147: 10-Parameter Urine Reagent Strip (glucose, bilirubin, ketone, S. G., blood, pH, protein, urobili
• 10763924410146: 4-Parameter Urine Reagent Strip (Glucose, Protein, Nitrite, Leukocytes
• 10763924210142: 2 Parameter Urine Reagent Strip (Glucose, Protein)