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Silaris RSV Control Kit

FDA UDI

Class II (US FDA UDI)

by Mesa Biotech, Inc.

Identity

Trade Name
Silaris RSV Control Kit FDA UDI
Generic Name
Respiratory syncytial virus (RSV) nucleic acid IVD, control FDA UDI
Device Name
The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test FDA UDI
Model / Reference
1029 FDA UDI
Description
The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test FDA UDI

Identifiers

Catalog Number
1029 FDA UDI
Primary DI / UDI-DI
B54010290 FDA UDI
FDA Product Code
OCC FDA UDI
GMDN Term
Respiratory syncytial virus (RSV) nucleic acid IVD, control 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: Respiratory syncytial virus (RSV) nucleic acid IVD, control

Silaris RSV Control Kit by Mesa Biotech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory syncytial virus (RSV) nucleic acid IVD, control.

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 68e891c1-7374-4098-889a-6b51fbfa8ba6 36 fields · synced May 29, 2026