DEVICE: Negative DAU Calibrator (B07600010)
Device Identifier (DI) Information
Negative DAU Calibrator
0001
In Commercial Distribution
0001
LIN-ZHI INTERNATIONAL, INC.
0001
In Commercial Distribution
0001
LIN-ZHI INTERNATIONAL, INC.
5mL/bottle.
Concentration: negative (drug-free) human urine.
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 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DLJ | Calibrators, Drug Specific |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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
609d2368-df10-4935-a134-7c2c1ca19e4e
March 29, 2018
2
July 19, 2016
March 29, 2018
2
July 19, 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