Identity
- Trade Name
- Fluoro-CheckTM Influenza A+B FDA UDI
- Generic Name
- Influenza A/B virus antigen IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients. FDA UDI
- Model / Reference
- TF8147 FDA UDI
- Description
- An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients. FDA UDI
Identifiers
- Catalog Number
- TF8147 FDA UDI
- Primary DI / UDI-DI
- 00895160002526 FDA UDI
- FDA Product Code
- PSZ FDA UDI
- GMDN Term
- Influenza A/B virus antigen IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3328 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
No
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: Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Fluoro-CheckTM Influenza A+B by Nano-Ditech Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Influenza A/B virus antigen IVD, kit, fluorescent immunoassay.
- Sofia — Quidel Corp. · Class I
- D3 Fastpoint — DIAGNOSTIC HYBRIDS, INC. · Class I
- D3 Ultra — DIAGNOSTIC HYBRIDS, INC. · Class I
- Sofia — Quidel Corp. · Class I
- IMAGEN Influenza Virus A and B — OXOID LIMITED · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA UDI 2f4d5839-a734-4d4c-bb8b-d9c83ea821a2 35 fields · synced Jun 9, 2026