DEVICE: ProScreen (00858998006548)

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Device Identifier (DI) Information

ProScreen
PSCup-10AB
PSCup-10AB
Instant Tech Subsidiary Acquisition
00858998006548
GS1
1
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+AMP+BUP
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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
LAF Gas Chromatography, Methamphetamine
JXM Enzyme Immunoassay, Benzodiazepine
DIS Enzyme Immunoassay, Barbiturate
DJC Thin Layer Chromatography, Methamphetamine
DJG Enzyme Immunoassay, Opiates
DKZ Enzyme Immunoassay, Amphetamine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ Enzyme Immunoassay, Cannabinoids
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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 2 and 30 Degrees Celsius
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 22, 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

[?]
1-888-669-4337
xxx@xx.xx
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