INSTANT-VIEW FOB Test

GUDID 10796918001785

INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette

ALFA SCIENTIFIC DESIGNS, INC.

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

• Primary Device ID: 10796918001785
• NIH Device Record Key: 10dc9364-4842-42b9-a05c-f4eb4f004cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTANT-VIEW FOB Test
• Version Model Number: 05-7602-2
• Company DUNS: 176391167
• Company Name: ALFA SCIENTIFIC DESIGNS, INC.
• Device Count: 2
• 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	00796918001788 [Unit of Use]
GS1	10796918001785 [Primary]

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

On-Brand Devices [INSTANT-VIEW FOB Test]

• 10796918001907: INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette
• 10796918001785: INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette
• 10796918001778: INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette
• 10796918002096: INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette