Identity
- Trade Name
- SilarisTM Influenza A&B Starter Pack FDA UDI
- Generic Name
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location. FDA UDI
- Model / Reference
- 1028 FDA UDI
- Description
- The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location. FDA UDI
Identifiers
- Catalog Number
- 1028 FDA UDI
- Primary DI / UDI-DI
- B54010280 FDA UDI
- 510(k) Number
- K171641 FDA UDI
- FDA Product Code
- OZE FDA UDIOCC 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
No
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: Thermal cycler nucleic acid amplification analyser IVD, point-of-careInfluenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
SilarisTM Influenza A&B Starter 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
- Sialris Influenza A&B Supplemental 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 391adfe8-0d6d-4210-947a-45e8cd05e12d 37 fields · synced May 30, 2026