Accutest iFOBT - Dual Sample Fecal Occult Blood Test

GUDID 10763924612250

Accutest iFOBT - Dual Sample Fecal Occult Blood Test Contains: 40 Test Kit (20 cassettes) with 25 patient specimen collection kits

JANT PHARMACAL CORPORATION

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

• Primary Device ID: 10763924612250
• NIH Device Record Key: 9d6a8035-fd87-47ea-84b5-04222ccff4a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest iFOBT - Dual Sample Fecal Occult Blood Test
• Version Model Number: CS612
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• Device Count: 1
• 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	10763924612250 [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

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