AccessGUDID - DEVICE: Silaris RSV Control Kit (B54010290)

GUDID

Device Identifier (DI) Information

Brand Name: Silaris RSV Control Kit
Version or Model: 1029
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1029
Company Name: MESA BIOTECH, INC.

Primary DI Number: B54010290
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056865474 *Terms of Use

Device Description: The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52818	Respiratory syncytial virus (RSV) nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from respiratory syncytial virus (RSV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCC	Respiratory Virus Panel Nucleic Acid Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 68e891c1-7374-4098-889a-6b51fbfa8ba6
Public Version Date: August 06, 2019
Public Version Number: 1
DI Record Publish Date: July 29, 2019