DEVICE: Negative DAU Calibrator (B07600010)

Device Identifier (DI) Information

Negative DAU Calibrator
0001
In Commercial Distribution
0001
LIN-ZHI INTERNATIONAL, INC.
B07600010
HIBCC

1
840839190 *Terms of Use
5mL/bottle. Concentration: negative (drug-free) human urine.
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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

[?]
Product Code Product Code Name
DLJ Calibrators, Drug Specific
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K020769 000
K023316 000
K031797 000
K032365 000
K032764 000
K033094 000
K090844 000
K102210 000
K113139 000
K113661 000
K120761 000
K120763 000
K133710 000
K141055 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

609d2368-df10-4935-a134-7c2c1ca19e4e
July 06, 2018
3
July 19, 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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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