DEVICE: Alere iCup Dx Pro 2 (00858945006812)

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Device Identifier (DI) Information

Alere iCup Dx Pro 2
I-DXP-167-02
I-DXP-167-02
Instant Technologies, Inc.
00858945006812
GS1
1
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC)
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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

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Product Code Product Code Name
LDJ Enzyme Immunoassay, Cannabinoids
JXM Enzyme Immunoassay, Benzodiazepine
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

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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

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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

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

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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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