ForSure iFOB Test Set

GUDID 30748349000022

ForSure iFOB test set Contains: 1 test device 1 test reagent buffer 1 sample collection set (may or may not be included)

SYNTRON BIORESEARCH, INC.

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

• Primary Device ID: 30748349000022
• NIH Device Record Key: 0ba012ab-6548-446c-a207-ad90e596d811
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ForSure iFOB Test Set
• Version Model Number: 10210
• Company DUNS: 174517060
• Company Name: SYNTRON BIORESEARCH, INC.
• 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: 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	00748349000021 [Primary]
GS1	10748349000028 [Package]; Contains: 00748349000021; Package: Kit Box [25 Units]; In Commercial Distribution
GS1	30748349000022 [Package]; Contains: 00748349000021; Package: Kit Box [50 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by SYNTRON BIORESEARCH, INC.

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