Accutest iFOBT - Specimen Collection Kit

GUDID 10763924620552

Accutest iFOBT - Specimen Collection Kit Contains: 25 Patient specimen mailers collection kit

JANT PHARMACAL CORPORATION

Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10763924620552
• NIH Device Record Key: 60286de9-2451-48c0-9fc6-21b6c337ec90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest iFOBT - Specimen Collection Kit
• Version Model Number: CS620
• 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	00763924620555 [Unit of Use]
GS1	10763924620552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063693

FDA Product Code

• KHE: Reagent, Occult Blood

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: 2020-04-06
• Device Publish Date: 2016-09-23

Devices Manufactured by JANT PHARMACAL CORPORATION

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• 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.