1
00884883012912
10018522
DRI Methadone Metabolite Assay
MICROGENICS CORPORATION
2
00884883012547
10016425
CEDIA Methadone Assay
MICROGENICS CORPORATION
3
00884883012530
10016421
CEDIA Methadone Metabolite Assay
MICROGENICS CORPORATION
4
00884883012493
10016403
DRI Methadone Assay
MICROGENICS CORPORATION
5
00884883004320
1868217
CEDIA Methadone Metabolite Assay
MICROGENICS CORPORATION
6
00884883004313
1730916
CEDIA DAU Methadone
MICROGENICS CORPORATION
7
00884883004252
100096
CEDIA Methadone Metabolite (EDDP) Assay
MICROGENICS CORPORATION
8
00884883004214
100087
CEDIA Methadone Metabolite (EDDP) Assay
MICROGENICS CORPORATION
9
00884883003408
100115
DRI Methadone Metabolite Assay
MICROGENICS CORPORATION
10
00884883003392
0596
DRI Methadone Assay
MICROGENICS CORPORATION
11
00884883002920
100116
DRI Methadone Metabolite Assay
MICROGENICS CORPORATION
12
00884883002913
0597
DRI Methadone Assay
MICROGENICS CORPORATION
13
00884883001503
100097
CEDIA Methadone Assay
MICROGENICS CORPORATION
14
00884883001442
100088
CEDIA Methadone Assay
MICROGENICS CORPORATION
15
00868754000208
X13-DT13A
X13-DT13A
THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA5
(View more)
THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr,Ni,pH,Bl,S.G. drugs of abuse test cup
(View less)
Coastline Explorer Cup
COASTLINE MEDICAL MANAGEMENT, LLC
16
00868401000254
RC12TCA
RC12TCA
(BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G.
RealityCHECK Drugs of Abuse Cup
WOLFE & ASSOCIATES INC
17
00867802000290
BS-0610S
301
The xReader System consists of a small, portable high resolution flatbed scanner
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The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine.The xReader System detects drug classes at the following cutoff concentrations: Amphetamines at 500 ng/mL; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCup may consist of any combination of the listed drug analytes.The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually.
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xReader System
ESCREEN, INC.
18
00863480002106
60B02
LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml
(View more)
LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml
(View less)
LifeSign QuikScreen 11
LIFESIGN L.L.C.
19
00859144006238
61127D
61127D
AMP/OPI300/COC/THC/MET/BZO/BAR/MTD/OXY/MDMA/BUP drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
20
00859144006221
61230D
61230D
THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
21
00859144006153
60960D
60960D
THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
22
00859144006139
61020D
61020D
THC/COC/AMP/PCP/OPI/MET/BAR/BZO/MTD/OXY drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
23
00859144006122
61023D
61023D
THC/COC/BAR/BZO/MET/OPI300/MTD/PPX/OXY/MDMA drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
24
00859144006092
61055D
61055D
THC/COC/AMP/MET/BAR/BZO/OPI/PCP/MDMA/MTD drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
25
00859144006085
61085D
61085D
THC/COC/AMP/MET/BAR/BZO/OPI/PCP/PPX/MTD drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
26
00859144006078
61205D
61205D
COC/THC/MET/OPI/AMP/MDMA/BAR/BZO/MTD/PPX/OXY/BUP drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
27
00859144006061
61210D
61210D
COC/THC/MET/OPI/AMP/BAR/BZO/MTD/PCP/PPX/OXY/BUP drugs of abuse test cup
DrugSmart Cup
TWIN SPIRIT INC.
28
00859144006054
C-61203D
C-61203D
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse te
(View more)
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED)
(View less)
DrugSmart Cup
TWIN SPIRIT INC.
29
00859144006047
C-61103D
C-61103D
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cu
(View more)
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
(View less)
DrugSmart Cup
TWIN SPIRIT INC.
30
00859144006030
C-61026D
C-61026D
THC, COC, OPI300, AMP, MET, PCP, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
DrugSmart Cup
TWIN SPIRIT INC.
31
00859144006023
C-60823D
C-60823D
THC, COC, OPI300, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
DrugSmart Cup
TWIN SPIRIT INC.
32
00859144006016
C-60820D
C-60820D
THC, COC, OPI, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
DrugSmart Cup
TWIN SPIRIT INC.
33
00858998006999
PSCupA-12BB-W
PSCupA-12BB-W
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+B
(View more)
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
(View less)
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
34
00858998006975
PSCup-10CT
PSCup-10CT
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
35
00858998006951
PSD-10M
PSD-10M
Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+MDMA+MTD+THC
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
36
00858998006937
PSD-10APO300
PSD-10APO300
Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(OXY/MDMA)+AMP+MTD+OPI300+PPX
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
37
00858998006920
PSD-9P
PSD-9P
Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
38
00858998006906
PSD-8BUP
PSD-8BUP
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
39
00858998006890
PSD-7MPB
PSD-7MPB
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+BZO+MTD+PCP
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
40
00858998006852
PSD-6MTDBO300
PSD-6MTDBO300
Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
41
00858998006746
PSP-10PPX
PSP-10PPX
Drugs of Abuse Test Cassette, (BAR/BZO)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD+PPX
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
42
00858998006739
PSP-10M
PSP-10M
Drugs of Abuse Test Cassette, (BAR/BZO)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD+MDMA
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
43
00858998006715
PSCupA-12PP
PSCupA-12PP
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+M
(View more)
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+MTD+PPX with Cr, Ni, pH, Bl, S.G.
(View less)
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
44
00858998006708
PSCupA-12TBU
PSCupA-12TBU
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+A
(View more)
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+AMP+BUP with Cr, Ni, pH, Bl, S.G.
(View less)
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
45
00858998006685
PSCupA-12M-W
PSCupA-12M-W
Drugs of Abuse Cup, CLIA Waived, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)
(View more)
Drugs of Abuse Cup, CLIA Waived, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G.
(View less)
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
46
00858998006678
PSCupA-12M
PSCupA-12M
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(
(View more)
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G.
(View less)
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
47
00858998006654
PSCupA-10MBO
PSCupA-10MBO
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+AMP+MTD+OXY+PPX with C
(View more)
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+AMP+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G.
(View less)
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
48
00858998006647
PSCupA-10AM
PSCupA-10AM
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+MTD wit
(View more)
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+MTD with Cr, Ni, pH, Bl, S.G.
(View less)
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
49
00858998006623
PSD-9CT
PSD-9CT
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION
50
00858998006562
PSCup-10MMO300
PSCup-10MMO300
Drugs of Abuse Cup, (BAR/BZO)+(COC/THC)+(OXY/MDMA)+AMP+MET1000+MTD+OPI300
ProScreen
INSTANT TECH SUBSIDIARY ACQUISITION