Identity
- Trade Name
- ID NOW Influenza A & B 2 FDA UDI
- Generic Name
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens. FDA UDI
- Model / Reference
- 427-000 FDA UDI
- Description
- A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010422 FDA UDI
- FDA Product Code
- PSZ FDA UDIOCC FDA UDIOOI FDA UDI
- GMDN Term
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3328 FDA UDI866.3980 FDA UDI862.2570 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: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
ID NOW Influenza A & B 2 by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- SilarisTM Influenza A&B Starter Pack — MESA BIOTECH, INC. · Class II
- Sialris Influenza A&B Supplemental Pack — MESA BIOTECH, INC. · Class II
- cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System — Roche Molecular Systems, Inc. · Class II
- Solana — DIAGNOSTIC HYBRIDS, INC. · Class II
- Silaris Influenza A&B Test — MESA BIOTECH, INC. · Class II
- Lyra — DIAGNOSTIC HYBRIDS, INC. · Class II
- Accula Flu A / B Test — MESA BIOTECH, INC. · Class II
- Xpert Xpress Flu — CEPHEID · Class II
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 |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 3ddde242-87cc-4402-b14a-80de6f0b94a1 33 fields · synced May 29, 2026