Identity
- Trade Name
- Red Tunica FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- RT-20134 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- RT-20134 FDA UDI
- Primary DI / UDI-DI
- 00810160810377 FDA UDI
- FDA Product Code
- GQG FDA UDI
- GMDN Term
- Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Red Tunica by Rodimedi & Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical.
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- QuickVue — Quidel Corp. · Class I
- Sofia — Quidel Corp. · Class I
- BinaxNOW RSV — Alere Scarborough, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rodimedi & Associates, Inc.
Sources (1)
- FDA UDI b532f122-4491-4732-8205-34cd1395fca5 36 fields · synced May 30, 2026