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

GMDN Preferred Term Name GMDN Definition
Multiple clinical chemistry analyte IVD, calibrator A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.
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FDA Product Code

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Product Code Product Code Name
DKB Calibrators, Drug Mixture
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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
March 29, 2018
2
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)

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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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