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.
0852
In Commercial Distribution
0852
LIN-ZHI INTERNATIONAL, INC.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DKB | Calibrators, Drug Mixture |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133710 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d8ea2184-523b-498b-84ab-22b3e649f9e9
August 24, 2018
4
July 05, 2016
August 24, 2018
4
July 05, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined