Red Tunica RT-20132

GUDID 20850036464666

The RedTunica™ One Step iFOB is a rapid immunoassay for the qualitative detection of human occult blood in human fecal specimens.

Rodimedi & Associates, Inc.

Faecal occult blood IVD, kit, rapid ICT, clinical

• Primary Device ID: 20850036464666
• NIH Device Record Key: c1890073-4111-458a-98ba-5ffbf4e1e230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Red Tunica
• Version Model Number: RT-20132
• Catalog Number: RT-20132
• Company DUNS: 785417726
• Company Name: Rodimedi & Associates, Inc.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com
• Phone: 18883159472
• Email: jrodriguez@rodimedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850036464662 [Primary]
GS1	20850036464666 [Unit of Use]

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: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [Red Tunica]

• 00850036464815: RedTunica™ Disposable Hypodermic Needle 27G x 1-1/2" - Sterile hypodermic needles intended to
• 00810160810162: RedTunica™ Disposable Hypodermic Needle 25G x 5/8" - Sterile hypodermic needles intended to in
• 00810160810131: RedTunica™ Disposable Hypodermic Needle 23G x 1" - Sterile hypodermic needles intended to inje
• 00810160810100: RedTunica™ Disposable Hypodermic Needle 22G x 1-1/2" - Sterile hypodermic needles intended to
• 00810160810070: RedTunica™ Disposable Hypodermic Needle 21G x 1-1/2" - Sterile hypodermic needles intended to
• 00810160810049: RedTunica™ Disposable Hypodermic Needle 20G x 1-1/2" - Sterile hypodermic needles intended to
• 00810160810018: RedTunica™ Disposable Hypodermic Needle 18G x 1-1/2" - Sterile hypodermic needles intended to
• 20850036464666: The RedTunica™ One Step iFOB is a rapid immunoassay for the qualitative detection of human occ
• 10810160810411: RedTunica™ SediRedi™ - Autozero Westergren ESR System is a quantitative, non-specific, eryth
• 00810160810360: The RedTunica™ RSV Antigen Test is a rapid immunochromatographic assay for the qualitative det