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Silaris RSV Supplemental Pack

FDA UDI

Class II (US FDA UDI)

by Mesa Biotech, Inc.

Identity

Trade Name
Silaris RSV Supplemental Pack FDA UDI
Generic Name
Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA. The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinical and epidemiological risk factors. FDA UDI
Model / Reference
1040 FDA UDI
Description
The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA. The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinical and epidemiological risk factors. FDA UDI

Identifiers

Catalog Number
1040 FDA UDI
Primary DI / UDI-DI
B54010400 FDA UDI
FDA Product Code
OCC FDA UDI
GMDN Term
Respiratory syncytial virus (RSV) 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: Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Silaris RSV Supplemental Pack 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, kit, nucleic acid technique (NAT).

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 69b4d161-aa2f-49be-b362-205286103ec9 36 fields · synced Jun 8, 2026