Accutest

GUDID 10763924410146

4-Parameter Urine Reagent Strip (Glucose, Protein, Nitrite, Leukocytes

JANT PHARMACAL CORPORATION

Urine catalase IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 10763924410146
• NIH Device Record Key: 5732af5b-8c41-4bbd-8ff7-168020a83710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest
• Version Model Number: UA704A
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• Device Count: 100
• 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	00763924410149 [Unit of Use]
GS1	10763924410146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052719

FDA Product Code

• JMT: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

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: 2022-11-28
• Device Publish Date: 2016-09-24

On-Brand Devices [Accutest]

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• 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)