ProScreen

GUDID 00817405020591

Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817405020591
NIH Device Record Key4ce90d51-9cb9-4077-a6df-a1f9ff921386
Commercial Distribution StatusIn Commercial Distribution
Brand NameProScreen
Version Model NumberPSCupA-5M-W
Company DUNS019410187
Company NameInstant Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com
Phone1-800-340-4029
Emailqa.portsmouth@abbott.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817405020591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-22
Device Publish Date2019-10-14

On-Brand Devices [ProScreen]

00817405020904Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD+PPX with Cr, Ni, pH,
00817405020898Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni,
00817405020881Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
00817405020850Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+BZO+OPI300 with C
00817405020836Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+MDMA+MET1000+OPI300+OXY with Cr, Ni, pH, Bl, S.G.
00817405020812Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC with Cr, Ni, pH, Bl, S.G.
00817405020805Drugs of Abuse Test Card, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, S.G.
00817405020775Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
00817405020768Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+MTD+PPX
00817405020751Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+BUP+MTD
00817405020744Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
00817405020737Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
00817405020720Drugs of Abuse Test Card, (MET1000/OPI2000)+BZO+COC+OXY+THC
00817405020713Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BZO+COC+THC
00817405020706Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC
00817405020690Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC
00817405020676Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl
00817405020652Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
00817405020621Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G.
00817405020614Drugs of Abuse Cup, CLIA Waived, AMP/BZO/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
00817405020591Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
00817405020584Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC

Trademark Results [ProScreen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROSCREEN
PROSCREEN
78921741 not registered Dead/Abandoned
PROFILES INTERNATIONAL, INC.
2006-07-03
PROSCREEN
PROSCREEN
78436669 3049082 Dead/Cancelled
STEDMAN CORPORATION
2004-06-17
PROSCREEN
PROSCREEN
78116161 2770361 Dead/Cancelled
SUPERNUS PHARMACEUTICALS, INC.
2002-03-20
PROSCREEN
PROSCREEN
76621760 3093738 Live/Registered
INSTANT TECH ACQUISITION SUBSIDIARY INC.
2004-11-22
PROSCREEN
PROSCREEN
76146090 not registered Dead/Abandoned
THOMAS EQUIPMENT LTD.
2000-10-13
PROSCREEN
PROSCREEN
74644155 2050214 Dead/Cancelled
KONINKLIJKE PHILIPS ELECTRONICS N.V.
1995-03-09
PROSCREEN
PROSCREEN
74501165 1934177 Dead/Cancelled
GOLFERS 911, INC.
1994-03-15
PROSCREEN
PROSCREEN
74442428 1846512 Dead/Cancelled
Knight Manufacturing Corporation
1993-09-28
PROSCREEN
PROSCREEN
73791338 1640976 Dead/Cancelled
PROGENICS PHARMACEUTICALS, INC.
1989-04-05
PROSCREEN
PROSCREEN
73307562 1213071 Dead/Cancelled
Tetko Inc.
1981-04-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.