Product Manual
Table Of Contents
Procedural Notes
Anterior Nasal Swab Collecon
.
the pouch.
1
2
Rapid Diagnosc Test for the Detecon of
For in vitro
The CareStart-
-
-
t.
F
-
The CareStart
CareStart
CareStart
Summary and Explanaon of the Test
Principles of the Test
The CareStart-
-
N-
.
T
Description of
Symbols
In vitro diagnosc medical device
in vitro
Batch code
Catalog number
Date of manufacture
Temperature limit
Do not use if the package is damaged
Contains sufficient for <n> tests
Prescripon-only
Negave control
.
Cauon
Do not re-use
Use by date
Consult instrucons for use
Manufacturer
Posive control
!
Apr. 15, 2021
Manufactured by:
Access Bio, Inc.
Manufactured for:
Intrivo Diagnoscs, Inc.
Technical Support in the U.S.
SARS-CoV-2 Angen
Intended Use
RCHM-02071
Package Insert
(Instrucons for Use)
Angen
Warnings and Precauons
in vitro
-
Procedural Notes
Nasopharyngeal Swab Collecon
Swab Sample Collecon Procedure
the pouch.
1
2
to
4
3
Storage and Stability
Quality Control
Internal Quality Control:
The CareStart
-
External Control:
CareStart
Specimen Collecon and Handling
CareStart™
Timer
Test device
Extracon vial / cap
Posive control swab
Nasal
(or nasopharyngeal)
swab
Negave control swab
Package insert
Quick Reference
Instrucons (QRI)
Reagents and Materials Provided
.
The CareStart