Product Manual

1024
Instructions For Use
In Vitro Diagnostics
Use by
YYYY-MM-DD
Temperature
Single-use
only. Do Not
Reuse.
Product Catalog
Number
KEY TO COMPONENT LABELING
IVD
2
Influenza A&B Control Kit Instructions for Use
INTENDED USE
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.
SUMMARY
The Silaris Influenza A&B Control Kit provides swabs coated with dried, inactivated
influenza A or influenza B virus. The level of influenza A or influenza B virus applied to
the swab is sufficient to provide a positive result when used with the Silaris Influenza
A&B Test. The influenza A control swab acts as a negative control for influenza B; the
influenza B control swab serves as a negative control for influenza A. When used for
quality control in the Silaris Influenza A&B Test, these controls are useful as an aid in
verifying test and operator performance.
MATERIALS PROVIDED:
• 5 - Influenza A Positive Control Swab (Yellow Shaft) contains inactivated influenza
A virus dried onto a swab.
• 5 - Influenza B Positive Control Swab (Blue Shaft) contains inactivated influenza
B virus dried onto a swab.
• Instructions For Use
MATERIALS REQUIRED BUT NOT PROVIDED
• Silaris Influenza A&B Test (Catalog #1027)
• Silaris Dock (Catalog #1026)
WARNINGS AND PRECAUTIONS
• For in vitro diagnostic use.
• Federal Law restricts sale of this product to or on the order of a licensed practitioner.
• To be used in conjunction with the Silaris™ Influenza A&B Test and the Silaris Dock.
• DO NOT use the Controls past their expiration date.
• Inactivated and dried viruses are used to make the control swabs. However, control
swabs and used cassettes should be handled as though they could transmit disease.
Observe established precautions against microbial hazards during use and disposal.
• Wear protective clothing such as laboratory coats, disposable gloves, and eye
protection when handling samples.
• Do not use any damaged kit contents.
• Do not touch the heads of the Control swabs. Cross contamination may occur due
to the high sensitivity of the test.
• Follow proper infection control guidelines for handling all specimens and related
items. Properly dispose of all contaminated waste according to federal, state, and
local requirements.
• Not for patient use
• Swabs stored in foil pouch at 150- 300C (590-860F) are stable until the expiration date
printed on the pouch.
STORAGE
• The Silaris Influenza A&B Control Kit must be stored at 150-30°C (590 - 86°F).
• The swabs should be kept in the pouch until testing.
INSTRUCTIONS FOR USE
• Process the Silaris™ Influenza A&B Control swabs as you would a patient sample in
accordance with the procedure for the Silaris™ Influenza A&B Test (Catalog #1027).
Read the instructions for use prior to utilizing the Silaris™ Influenza Control Kit.
EXPECTED RESULTS
• The Positive A Control should yield a positive A result and a negative result for B.
• The Positive B Control should yield a positive B result and a negative result for A.
DISPOSING OF MATERIAL
• Discard of hazardous or biologically contaminated materials according to your
institutions practices. Discard all materials in a safe and acceptable manner that is
in compliance with all country, state, and local requirements.
REORDER NUMBER
Catalog No. 1024 Silaris™ Influenza A&B Control Kit
Catalog No. 1027 Silaris™ Influenza A&B Test
Catalog No. 1026 Silaris™ Dock
TECHNICAL ASSISTANCE
If External QC testing fails, repeat the test using a new Control swab, reagents and test
cassettes or contact Sekisui Diagnostics Technical Support for assistance, Monday through
Friday from 8:30 a.m. to 5:00 p.m. Eastern Standard Time at 800-332-1042 (US Only) or
781-652-7800 (outside the US), before continuing with further samples.
Product Batch
Number
IVD
Caution: Federal Law
restricts this device to
sale by or on the order
of a licensed practitioner.
MF
Manufactured For
Contents
Manufacturer
Positive Control
Negative
Control
P/N 60016 Rev. A (2018-2)