Red Tunica RT-20134

GUDID 00810160810360

The RedTunica™ RSV Antigen Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infections. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age.

Rodimedi & Associates, Inc.

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810160810360
• NIH Device Record Key: b532f122-4491-4732-8205-34cd1395fca5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Red Tunica
• Version Model Number: RT-20134
• Catalog Number: RT-20134
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM
• Phone: 1-888-315-9472
• Email: JRODRIGUEZ@RODIMEDI.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810160810360 [Unit of Use]
GS1	00810160810377 [Primary]

FDA Product Code

• GQG: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

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

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