|
510K # |
Product |
Cut-Off |
Product Code |
Notified: |
CLIA Status |
|
K020771 |
One Step Drug Screen Test Card; One Step Drug Screen Test Card With
Integrated Cup |
see below |
DJG; LCM; DKZ; DIS; JXM; LDJ; DIO; DPK; DJR |
May 15, 2002 |
|
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
MAMP |
1000 ng/mL |
|
|
|
|
|
MOP 300 or OPI 300 |
300 ng/mL |
|
|
|
|
|
MTD |
300 ng/mL |
|
|
|
|
|
OPI 2000 |
2000 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
K020313 |
One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug
Multi-Line Screen Test Device |
see below |
DKZ; DIO; LDJ; DJG; LCM; LAF |
May 8, 2002 |
|
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
MAMP |
1000 ng/mL |
|
|
|
|
|
OPI 2000 |
2000 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
K023946 |
One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug
Multi-Line Screen Test Device |
see below |
DJC; DJG; DIS; JXM; DJR; LFG |
Feb. 5, 2003 |
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
MTD |
300 ng/mL |
|
|
|
|
|
MDMA |
500 ng/mL |
|
|
|
|
|
MOP 300 or OPI 300 |
300 ng/mL |
|
|
|
|
|
TCA |
1000 ng/mL |
|
|
|
|
K031759 |
Multi-Drug Multi Line Drug Screen Test Card with Integrated Cup |
|
LDJ; DIO; DJC; DKZ; DJG; LCM; JXM; DJR; DIS; LFG |
August 4, 2003 |
|
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
MAMP |
1000 ng/mL |
|
|
|
|
|
OPI 2000 |
2000 ng/mL |
|
|
|
|
|
MOP 300 |
300 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
MTD |
300 ng/mL |
|
|
|
|
|
MDMA |
500 ng/mL |
|
|
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
TCA |
1000 ng/mL |
|
|
|
|
K011673 |
AMP - One Step Amphetamine Test Strip; One Step Amphetamine Test Device |
1000 ng/mL |
DKZ |
July 31, 2001 |
|
|
K041822 |
AMP - One Step Amphetamine Test Strip; One Step Amphetamine Test Device |
300 ng/mL |
DKZ |
July 6, 2004 |
|
|
K011672 |
mAMP - One Step Methamphetamine Test Strip; One Step Methamphetamine
Test Device |
1000 ng/mL |
LAF |
July 31, 2001 |
|
|
K033299 |
mAMP - One Step Methamphetamine Test Strip; One Step Methamphetamine
Test Device |
500 ng/mL |
LAF |
December 12, 2003 |
|
|
K012824 |
BAR - One Step Barbiturate Test Strip; One Step Barbiturate Test Device |
300 ng/mL |
DIS |
November 9, 2001 |
|
|
K012300 |
BZO - One Step Benzodiazepine Test Strip; One Step Benzodiazepine Test
Device |
300 ng/mL |
JXM |
September 17, 2001 |
|
|
K010841 |
COC - One Step Cocaine Test Strip; One Step Cocaine Test Device |
300 ng/mL |
DIO |
July 9, 2001 |
|
|
K032903 |
COC - One Step Cocaine Test Strip; One Step Cocaine Test Device |
150 ng/mL |
DIO |
February 17, 2004 |
|
|
K013380 |
MOP - |