Silaris RSV Supplemental Pack 1040

GUDID B54010400

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.

MESA BIOTECH, INC.

Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	B54010400
NIH Device Record Key	69b4d161-aa2f-49be-b362-205286103ec9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Silaris RSV Supplemental Pack
Version Model Number	1040
Catalog Number	1040
Company DUNS	056865474
Company Name	MESA BIOTECH, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	800-332-1042
Email	sdadiagnosticstsdl@sekisuidiagnostics.com

Operating and Storage Conditions

Storage Environment Temperature

Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B54010400 [Primary]

FDA Product Code

OCC	Respiratory Virus Panel Nucleic Acid Assay System

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-01-28
Device Publish Date	2019-07-29

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