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.
0857
In Commercial Distribution
0857
LIN-ZHI INTERNATIONAL, INC.
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.
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? |
---|---|---|---|---|
55461 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DIF | Drug Mixture Control Materials |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133710 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
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
19e05f63-1c8f-4032-87ee-f657260fce9b
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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