DEVICE: U-Screen (00858998006135)

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Device Identifier (DI) Information

U-Screen
USSCupA-12NTCLIA
USSCupA-12NTCLIA
Instant Tech Subsidiary Acquisition
00858998006135
GS1
1
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
Yes
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
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FDA Product Code

[?]
Product Code Product Code Name
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
DJR Enzyme Immunoassay, Methadone
LCM Enzyme Immunoassay, Phencyclidine
JXM Enzyme Immunoassay, Benzodiazepine
DIS Enzyme Immunoassay, Barbiturate
LAF Gas Chromatography, Methamphetamine
DKZ Enzyme Immunoassay, Amphetamine
DJG Enzyme Immunoassay, Opiates
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 26, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
888.669.4337
james.harvey@usdiagnostics.com
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