Identity
- Trade Name
- FLU/RSV Positive Control FDA UDI
- Generic Name
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control FDA UDI
- Device Name
- FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program FDA UDI
- Model / Reference
- 751110 FDA UDI
- Description
- FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program FDA UDI
Identifiers
- Catalog Number
- 751110 FDA UDI
- Primary DI / UDI-DI
- 00840733101977 FDA UDI
- 510(k) Number
- K071101 FDA UDI
- FDA Product Code
- GQG FDA UDI
- GMDN Term
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3480 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
FLU/RSV Positive Control by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K071101 also covers:
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 db9fefcd-9c8a-4a2d-9bc9-a746f737af0d 38 fields · synced Jun 1, 2026