U-Screen USSCupA-12

GUDID 00858998006098

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 12 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BZO/BUP/MDMA/MTD/OXY/PPX)

Instant Tech Subsidiary Acquisition

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00858998006098
NIH Device Record Key331b56f1-616b-4497-89d0-e715b4d026f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-Screen
Version Model NumberUSSCupA-12
Catalog NumberUSSCupA-12
Company DUNS080317182
Company NameInstant Tech Subsidiary Acquisition
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-Countertrue

Customer Support Contacts

Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com
Phone888.669.4337
Emailjames.harvey@usdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858998006098 [Primary]

FDA Product Code

DJREnzyme Immunoassay, Methadone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-26

On-Brand Devices [U-Screen]

00858998006418U-Screen Squared Integrated Cup with 4 Panel Drug Screen for (COC/OPI2000/AMP/MET).
008589980061976-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/AMP/MET/BZO)
00858998006180U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for
00858998006173U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP
00858998006166U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) for (THC/COC/OPI
00858998006159U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI
00858998006142U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI
00858998006135U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen fo
00858998006128U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for
00858998006111U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for
00858998006104U-Screen Squared Integrated Cup with Adulterants(CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP
00858998006098U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 12 Panel Drug Screen for (THC/COC/OP
00858998006081U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for
00858998006074U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/MO
00858998006067U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/OP
00858998006050U-Screen Squared Integrated CLIA Waived Cup 7 Panel Drug Screen for (THC/COC/OPI300/AMP/BUP/BZO/
00858998006043U-Screen Squared Integrated Cup 5 Panel Drug Screen for (THC/COC/OPI2000/MET/BZO)
00858998006036U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
00858998006029UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
00858998006012U-Screen Squared Integrated Cup 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MD
008589980060056-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/MAMP/BZO/OXY)
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