DEVICE: Multi-Analyte DAU Calibrator Set C, Low Calibrator (B07608520)

Device Identifier (DI) Information

Multi-Analyte DAU Calibrator Set C, Low Calibrator
0852
In Commercial Distribution
0852
LIN-ZHI INTERNATIONAL, INC.
B07608520
HIBCC

1
840839190 *Terms of Use
15mL/bottle. Concentration of Multi-Analyte: 75 ng/mL benzoylecgonine, 250 ng/mL d-methamphetamine, 150 ng/mL methadone, 1000 ng/mL morphine, 100 ng/mL oxazepam, and 100 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

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
55460 Multiple drugs of abuse IVD, calibrator
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DKB Calibrators, Drug Mixture
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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

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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 Record Status

d8ea2184-523b-498b-84ab-22b3e649f9e9
August 24, 2018
4
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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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