Identity
- Trade Name
- TRU RSV FDA UDI
- Generic Name
- Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to be used by clinical laboratories to test specimens from symptomatic patients aged five years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture. The results of this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections. FDA UDI
- Model / Reference
- 751330 FDA UDI
- Description
- TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to be used by clinical laboratories to test specimens from symptomatic patients aged five years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture. The results of this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections. FDA UDI
Identifiers
- Catalog Number
- 751330 FDA UDI
- Primary DI / UDI-DI
- 00840733101847 FDA UDI
- 510(k) Number
- K071101 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
No
FDA UDI
Category: Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Tru Rsv by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical.
- BD Veritor™ System For Rapid Detection of RSV - Laboratory kit — BECTON DICKINSON AND COMPANY · Class I
- BinaxNOW RSV — Alere Scarborough, Inc. · Class I
- Nano-Check RSV Test — Nano-Ditech Corporation · Class I
- QuickVue — Quidel Corp. · Class I
- BD Veritor™ System For Rapid Detection of RSV - CLIA waived kit — BECTON DICKINSON AND COMPANY · Class I
- 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
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI fa06a8be-f716-4805-b6bf-802631dc43a2 37 fields · synced Jun 8, 2026