DEVICE: Multi-Analyte DAU Control Set C, Level 1 Control (B07608570)

Device Identifier (DI) Information

Multi-Analyte DAU Control Set C, Level 1 Control
0857
In Commercial Distribution
0857
LIN-ZHI INTERNATIONAL, INC.
B07608570
HIBCC

1
840839190 *Terms of Use
15mL/bottle. Concentration of Multi-Analyte: 112.5 ng/mL benzoylecgonine, 375 ng/mL d-methamphetamine, 225 ng/mL methadone, 1500 ng/mL morphine, 150 ng/mL oxazepam, and 150 ng/mL secobarbital.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
DIF Drug Mixture Control Materials
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133710 000
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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 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

19e05f63-1c8f-4032-87ee-f657260fce9b
August 24, 2018
4
July 05, 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

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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

[?]
No Customer Contact currently defined
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