Identity
- Trade Name
- Sialris Influenza A&B Supplemental Pack FDA UDI
- Generic Name
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. FDA UDI
- Model / Reference
- 1035 FDA UDI
- Description
- The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. FDA UDI
Identifiers
- Catalog Number
- 1035 FDA UDI
- Primary DI / UDI-DI
- B54010350 FDA UDI
- 510(k) Number
- K171641 FDA UDI
- FDA Product Code
- OCC 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
- 866.3980 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)
Sialris Influenza A&B Supplemental Pack by Mesa Biotech, 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).
- 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
- ID NOW Influenza A & B 2 — Alere Scarborough, Inc. · Class II
- Lyra — DIAGNOSTIC HYBRIDS, INC. · Class II
- Xpert Xpress Flu — CEPHEID · Class II
- cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System — Roche Molecular Systems, Inc. · Class II
- cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System — Roche Molecular Systems, Inc. · Class II
- SilarisTM Influenza A&B Starter Pack — MESA BIOTECH, INC. · Class II
Cleared under the same submission
K171641 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mesa Biotech, Inc.
Sources (1)
- FDA UDI 1357f493-a91d-401f-85bb-407e8db8971f 37 fields · synced May 30, 2026