Thermo Scientific BRAHMS KRYPTOR compact PLUS - INDICATIONS FOR USE

INDICATIONS
FOR
USE
510(k)
Number
(if
known):
K070310
Device
Name:
B.R.A.H.M.S
PCT
sensitive
KRYPTOR
®
Test
System
Sponsor
Name:
B-R.A.H.M.S
Aktiengesellschaft
Indications
for
Use:
The
B.R.A.H.M.S
PCT
sensitive
KRYPTOR®
is
designed
for
automated
detection
of
PCT
(procalcitonin)
in
human
serum
or
plasma
(EDTA,
heparin)
samples
by
the
immunofluorescent
B.R.A.H.M.S
PCT
sensitive
KRYPTOR®
assay.
The
B.R.A.H.M.S
PCT
sensitive
KRYPTOR®
is
intended
for
use
in
conjunction
with
other
laboratory
findings
and
clinical
assessments
to
aid
in
the
risk
assessment
of
critically
ill
patients
on
their
first
day
of
ICU
admission
for
progression
to
severe
sepsis
and
septic
shock.
Prescription
Use
[
And/Or
Over-The-Counter
Use
[_
(21
CFR
801
Subpart
D)
(21
CFR
807
Subpart
C)
Do
Not
Write
Below
This
Line-
Continue
on
Another
Page
if
Needed
Concurrence
of
CDRH,
Office
of
In
Vitro
Diagnostic
Devices
(OIVD)
Diasin
Sign-O
Office
of
In
Vitro
Diagnostic
Device
Evaluation
and
Safety
SIA~k
v