DEVICE: Multi-Analyte DAU Control Set A, Level 1 Control (B07608170)

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Device Identifier (DI) Information

Multi-Analyte DAU Control Set A, Level 1 Control
0817
0817
LIN-ZHI INTERNATIONAL, INC.
B07608170
HIBCC
1
15mL/bottle. Concentration of Multi-Analyte: 112.5 ng/mL benzoylecgonine, 375 ng/mL d-methamphetamine, 225 ng/mL methadone, and 7.5 ng/mL 6-acetylmorphine.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Multiple urine analyte IVD, control A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.
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FDA Product Code

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Product Code Product Code Name
DIF Drug Mixture Control Materials
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 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
July 05, 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

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No Customer Contact currently defined
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