Identity
- Trade Name
- ImmunoCard STAT! FLU A&B FDA UDI
- Generic Name
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Immunocard STAT Flu A&B EUDAMEDImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs. FDA UDI
- Model / Reference
- 782030 EUDAMEDFDA UDI
- Description
- ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs. FDA UDI
Identifiers
- Catalog Number
- 782030 FDA UDI
- Primary DI / UDI-DI
- 00840733101656 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840733101656 EUDAMED
- 510(k) Number
- K083746 FDA UDI
- FDA Product Code
- PSZ FDA UDI
- EMDN Code
- W0105040504 INFLUENZA & PARA INFLUENZA - NA REAGENTS EUDAMED
- GMDN Term
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3328 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
ImmunoCard STAT! FLU A&B by Meridian Bioscience, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (2)
- FDA UDI 5791d527-bfd9-4d0a-9f76-55d9812da2cd 37 fields · synced Jun 19, 2026
- EUDAMED 3620f445-befb-4ea8-90ae-48133862329c 61 fields · synced Jun 19, 2026