Accutest iFOB Positive and Negative Hemoglobin Controls

GUDID 10763924607058

Accutest iFOB Positive and Negative Hemoglobin Controls Contains: 1 positive hemoglobin control and 1 negative hemoglobin control

JANT PHARMACAL CORPORATION

Biological fluid occult blood screening IVD, control

• Primary Device ID: 10763924607058
• NIH Device Record Key: b49ecb6e-d9fb-4c29-a7d4-e1f412aee31c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accutest iFOB Positive and Negative Hemoglobin Controls
• Version Model Number: CSC67
• 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: false
• Device Combination Product: false
• Single Use: false
• 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	10763924607058 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-20
• Device Publish Date: 2019-11-12

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