User Manual

RCPM-00279, RCPM-00479, RCPM-02079
Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
on/go
TM
COVID-19 Antigen Self-Test
IFU-RCPM79-E / Rev. A
ACCESS BIO, INC.
Page 16 of 16
Description of Symbols
Symbol
Descriptions
Symbol
Descriptions
In vitro diagnostic medical device
Indicates a medical device that is intended to be
used as an in vitro diagnostic medical device.
Catalog number
Indicates the manufacturer’s catalog number so
that the medical device can be identified.
Consult instructions for use
Indicates the need for the user to consult the
instructions for use.
Caution
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons, be
presented on the medical device itself.
Manufacturer
Indicates the medical device manufacturer.
Date of manufacture
Indicates the date when the medical device was
manufactured.
Batch code
Indicates the manufacturer’s batch code so that
the batch or lot can be identified.
Temperature limit
Indicates the temperature limits to which the
medical device can be safely exposed.
Do not re-use
Indicates a medical device that is intended for
one use, or uses on a single patient during a
single procedure.
Do not use if the package is damaged
Indicates a medical device that should not be
used if the package has been damaged or
opened.
Use by date
Indicates the date after which the medical
device is not to be used.
Contains sufficient for <n> tests
Indicates the total number of IVD tests that can
be performed with the IVD.
Prescription-only
Manufactured by:
Access Bio, Inc.
65 Clyde Road, Suite A.
Somerset, NJ 08873, USA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.accessbio.net
Manufactured for:
Intrivo Diagnostics, Inc.
2021 Santa Monica Blvd, #11
Santa Monica, CA 90404, USA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.intrivo.com
Technical Support in the U.S.
Tel: [phone] (Toll Free)
Website: letsongo.com/Support
Document number: IFU-RCPM79-E
Revision number: A (Effective date: August 2, 2021)