Identity
- Trade Name
- Silaris Dock FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
- Device Name
- The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette. FDA UDI
- Model / Reference
- 1026 FDA UDI
- Description
- The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette. FDA UDI
Identifiers
- Catalog Number
- 1026 FDA UDI
- Primary DI / UDI-DI
- B54010260 FDA UDI
- 510(k) Number
- K171641 FDA UDI
- FDA Product Code
- OZE FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Silaris Dock by Mesa Biotech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermal cycler nucleic acid amplification analyser IVD, point-of-care.
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- Fluorescence Quantitative PCR Detection System — Anitoa Biotechnology （Hangzhou）Co., Ltd. · Class II
- Fluorescence Quantitative PCR Detection System — Anitoa Biotechnology （Hangzhou）Co., Ltd. · Class II
- Fluorescence Quantitative PCR Detection System — Anitoa Biotechnology （Hangzhou）Co., Ltd. · Class II
- Fluorescence Quantitative PCR Detection System — Anitoa Biotechnology （Hangzhou）Co., Ltd. · Class II
- Fluorescence Quantitative PCR Detection System — Anitoa Biotechnology （Hangzhou）Co., Ltd. · Class II
- Fluorescence Quantitative PCR Detection System — Anitoa Biotechnology （Hangzhou）Co., Ltd. · Class II
Cleared under the same submission
K171641 also covers:
- Accula Flu A / B Control Kit — MESA BIOTECH, INC.
- Accula Flu A / B Test — MESA BIOTECH, INC.
- Sialris Influenza A&B Supplemental Pack — MESA BIOTECH, INC.
- Silaris Influenza A&B Control Kit — MESA BIOTECH, INC.
- Silaris Influenza A&B Test — MESA BIOTECH, INC.
- SilarisTM Influenza A&B Starter Pack — MESA BIOTECH, INC.
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 2f19e5cb-a808-4a67-9513-90b57c78703d 35 fields · synced May 30, 2026