NANOBIOSYM COVID-19 Nano-Saliva Collection Kit Instruction Manual
- June 3, 2024
- NANOBIOSYM
Table of Contents
Instructions For Use
The Nano-Saliva Collection Kit to be used with The Nano Test for COVID-19
Please read these instructions carefully before you start to collect the
sample.
Warnings: For use under Emergency Use Authorization (EUA) only. For in
vitro diagnostic use. For prescription use only. For use by individuals age 18
years or older. WARNING
Do not clean with any substance containing bleach. Do not use if kit is
expired. Cap is a choking hazard. Keep out of reach of children. Wash with
water if liquid solution comes in contact with eyes or skin. DO NOT INGEST
LIQUID. Avoid contact with skin and eyes. If contact with body occurs, rinse
with water. If irritation persists, seek medical advice. This kit is designed
for the collection of human saliva samples.
Nanobiosym Precision Testing Services 245 First Street, Suite 175, Cambridge,
MA 02142. Phone Number: (781)-391-7979 Nanobiosym. All Rights Reserved. Rx
Only. For in vitro diagnostic use. For use under Emergency Use Authorization
(EUA) only.
LABEL LEGEND
| Consult instructions for use
---|---
| Use by date
| Do not use if damaged
REF| Catalog number
SN| Serial number
**| Caution, consult instructions
| Temperature limits
| Manufacturer
LOT**| Batch code
| Single use only
Do NOT eat, drink (even water), smoke, or chew gum for 30 minutes before
collecting your saliva samples. If you are having trouble collecting saliva in
your mouth, try closing your mouth and wiggling your tongue, gently rubbing
the outside of your cheeks, just behind your back teeth, and making chewing
motions with your mouth. Wash your hands prior to and directly after
collection.
Note: You must collect your sample on the same day that you can ship your
sample and ensure delivery to our labs by 10:30am EST the following day.
Verify shipping pickup & delivery times before collecting your sample. Do NOT
register, collect, or ship your sample on a Saturday or Sunday. Nanobiosym
Precision Testing Services will only accept your sample if it reaches the
testing facility within 48 hours of being shipped and within 56 hours of being
collected. Any samples received outside of this window will be rejected.
Open the kit and place all the contents on a clean, dry surface.
Inspect your test kit to ensure all components are included. Your Kit Includes
Return Shipping Supplies! This includes a biohazard specimen bag (bio-bag)
with absorbent material, a return shipping label, and a shipping bag. Do NOT
discard these items. They are required for return shipping! 
*Please take a picture of your prepaid return label for tracking purposes.
1 Step
Register online right before saliva collection.
2 Step
Collect your sample.
Collection Video Tutorial: Please visit
https://vimeo.com/694268545
3 Step
Return your sample to us. (See additional insert for return shipping
instructions.) Promptly ship your sample back via your local courier facility.
Ship your sample
before the last pickup of the day. Please ensure that it will arrive before
10:30am EST the following day. Note: Do not ship from 3rd party locations (eg.
CVS, Walgreens, RiteAid, etc.)
Warning: This product has not been FDA cleared or approved, but has been
authorized for emergency use by FDA under an EUA for use by the authorized
laboratory. This product has been authorized only for the detection of nucleic
acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency
use of this product is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated or authorization is
revoked sooner. Saliva specimen will be collected at home or other collection
sites outside of the healthcare setting from individuals suspected of COVID-19
by their healthcare provider. Federal Law restricts this device to sale by or
on the order of a licensed practitioner. Only for 18+ use.
Do NOT eat, drink, smoke, or chew gum for 30-minutes before collecting your
sample.
your health in your hands®
Welcome to The Nano-Saliva Collection Kit to be used with The Nano Test for
COVID-19
Note: You must collect your sample on the same day that you can ship your
sample and ensure delivery to our labs by 10:30am EST the following day.
Verify shipping pickup & delivery times before collecting your sample. Do not
register, collect, or ship your sample on a Saturday or Sunday. Nanobiosym
Precision Testing Services will only accept your sample if it reaches the
testing facility within 48 hours of being shipped and within 56 hours of being
collected. Any samples received outside of this window will be rejected.
Register online right before saliva collection.
Warning: This product has not been FDA cleared or approved but has been
authorized for emergency use by FDA under an EUA for use by the authorized
laboratory. This product has been authorized only for the detection of nucleic
acid from SARS-CoV-2, not for any other viruses or pathogens; and the
emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated, or authorization is
revoked sooner.
LBL-NM-0236 rev7
Return The Nano-Saliva Collection Kit sample to us via
FedEx
SHIPPING REMINDER: You must collect your sample on the same day that you
can ship your sample and ensure delivery (via Fedex Priority Overnight) to our
labs by 10:30am EST the following day. Please check with your local FedEx to
ensure your sample ships same day. Please verify shipping pickup & delivery
times before collecting your sample. Do NOT register, collect, or ship your
sample on a Saturday or Sunday.
Nanobiosym Precision Testing Services will only accept your sample if it
reaches the testing facility within 48 hours of being shipped and within 56
hours of being collected. Any samples received outside of this window will be
rejected. Only samples that are shipped back and received Monday-Friday will
be accepted. Samples received on weekends may be rejected. You have 2 options
for shipping the sample. Visit
https://bit.ly/fedexdropbox to view FedEx drop
box locations and pickup schedules.
FedEx Drop Box
It’s important to bring your specimen to a drop box on the same day you collect it before the last Express pick up. Deliver your specimen to a drop box only after you have conÿrmed delivery (via Fedex Priority Overnight) to our labs by 10:30am EST the following day. Do not take it to a FedEx o°ce. Do not place kit in drop box on Saturday or Sunday. or
Schedule a FedEx Pickup
Schedule your FedEx pickup for a weekday and only after you have conÿrmed
delivery to our labs by 10:30am EST the following day. Call FedEx at
800-463-3339 and answer some questions.
FedEx: “What are you calling about?” You: “FedEx Express® return pickup”
FedEx: “…a pickup request for a return. To arrange a pickup for today or
tomorrow, depending on availability, say “pickup.” You: “Pickup”
FedEx: “Is the word “stamp” written anywhere on your return label?” You: “No”
FedEx: “What is the tracking number?” You: Provide the tracking number (TRK#)
from the prepaid FedEx return label.
FedEx: “What kind of return are you calling about?” You: “FedEx Express”
Provide additional information as requested. You may be asked for the pickup
location address, number of packages to be picked up, day and time window for
the pickup, or if your shipment is currently ready. Note the conÿrmation
pickup number provided. If you are asked for a credit card or account number,
state that this is a FedEx Express prepaid return pickup and provide the
tracking number (TRK#) from the return label.
NOTE: Please do not collect your specimen until you conÿrm pickup times
of the drop box or have conÿrmed your scheduled pickup. It is important to
bring your sample to a drop box on the same day you collect it before the last
Express pickup.
Warning: This product has not been FDA cleared or approved, but has been
authorized for emergency use by FDA under an EUA for use by the authorized
laboratory.
This product has been authorized only for the detection of nucleic acid from
SARS-CoV-2, not for any other viruses or pathogens; and The emergency use of
this product is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1)
of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the declaration is terminated, or authorization is revoked sooner. For
use under Emergency Use Authorization (EUA) only. For in vitro diagnostic use.
For prescription use only. For use by individuals age 18 years or older.
Return The Nano-Saliva Collection Kit sample to us via
UPS
SHIPPING REMINDER : You must collect your sample on the same day that you
can ship your sample and ensure delivery (via Next Day Air) to our labs by
10:30am EST the following day. Please check with your local UPS to ensure your
sample ships same day. Please verify shipping pickup & delivery times before
collecting your sample. Do NOT register, collect, or ship your sample on a
Saturday or Sunday. Nanobiosym Precision Testing Services will only accept
your sample if it reaches the testing facility within 48 hours of being
shipped and within 56 hours of being collected. Any samples received outside
of this window will be rejected. Only samples that are shipped back and
received Monday-Friday will be accepted. Samples received on weekends may be
rejected. You have 2 options for shipping the sample.
UPS Drop Box
Go to www.ups.com/dropo˜ to ÿnd an authorized UPS
drop o° location Monday through Friday. Be sure to drop o° your completed kit
before the latest ‘Air’ pickup on the same day you collect your sample.
Enter your ZIP code and check the box for “Find a drop o° location”. Click on
“Location Type” to reveal a number of di°erent options. Since this package
must be guaranteed Next Day Air Delivery by 10:30 am EST the following day,
you must select “The UPS Store” and “UPS Customer Center”. Note: Do not ship
from 3rd party locations (eg. CVS, Walgreens, RiteAid, etc.).
Click the “Find” button to list nearby authorized drop o° locations. Scroll
through the options to ÿnd the most convenient one for you. Operating hours
and phone numbers are provided. Do not place kit in drop box on Saturday or
Sunday.
Hand the sealed shipping package to the UPS representative and conÿrm that the
package will be picked up today. Please conÿrm that your sample will be
shipped to arrive at Nanobiosym Precision Testing Services by 10:30am EST the
following day. or
Schedule a UPS Pickup
Go to
wwwapps.ups.com/pickup/schedule to
schedule UPS to pick up this package at your address. Schedule your UPS pickup
for a weekday and only after you have conÿrmed delivery to our labs by 10:30am
EST the following day. You can also call UPS at
800-742-5877 and answer some questions.
UPS: “How can I help you today?” Your Answer: “Schedule Pickup”
UPS: “How many packages are you shipping?” You: “1”
UPS: “What is the tracking number?”
Your Answer: Say the Tracking # (begins with 1Z) from the pre-paid UPS return
label.
UPS: “What kind of return are you calling about?”
You: “UPS Next Day Air”
Provide additional information as requested. You may be asked for the pickup
location address, number of packages to be picked up, day and time window for
the pickup, or if your shipment is currently ready. Note the conÿrmation
pickup number provided. If you are asked for a credit card or account number,
state that this is a UPS return Next Day Air pickup and provide the Tracking #
(begins with 1Z) from the prepaid UPS return label. Please conÿrm that your
sample will be delivered to Nanobiosym Precision Testing Labs by 10:30 am EST
the following day.
NOTE: Please do not collect your specimen until you conÿrm pickup times
of the drop box or have conÿrmed your scheduled pickup. It is important to
bring your sample to a drop box on the same day you collect it before the last
UPS Next Day Air pickup.
Warning: This product has not been FDA cleared or approved, but has been
authorized for emergency use by FDA under an EUA for use by the authorized
laboratory.
This product has been authorized only for the detection of nucleic acid from
SARS-CoV-2, not for any other viruses or pathogens; and The emergency use of
this product is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1)
of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the declaration is terminated, or authorization is revoked sooner. For
use under Emergency Use Authorization (EUA) only. For in vitro diagnostic use.
For prescription use only. For use by individuals age 18 years or older.
References
- Nanobiosym Testing
- Order Lab Tests and Blood Tests Online | Testing.com
- Page Not Found | UPS - United States
- Schedule a Pickup | UPS - United States
- FedEx Drop Box Find a Location Near You
- Simple Steps for Saliva Collection.wmv on Vimeo
Read User Manual Online (PDF format)
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