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Silaris Influenza A&B Control Kit

FDA UDI

Class II (US FDA UDI)

by Mesa Biotech, Inc.

Identity

Trade Name
Silaris Influenza A&B Control Kit FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
Device Name
The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test. FDA UDI
Model / Reference
1024 FDA UDI
Description
The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test. FDA UDI

Identifiers

Catalog Number
1024 FDA UDI
Primary DI / UDI-DI
B54010240 FDA UDI
510(k) Number
K171641 FDA UDI
FDA Product Code
OCC 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

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: Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Silaris Influenza A&B Control Kit 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.

Cleared under the same submission

K171641 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mesa Biotech, Inc.

Sources (1)

  • FDA UDI 19ccc657-de8e-41ea-913c-4a0dc404b231 37 fields · synced May 30, 2026