DEVICE: Amphetamines 500 DAU Calibrator, Cutoff Calibrator (B07601030)

Device Identifier (DI) Information

Amphetamines 500 DAU Calibrator, Cutoff Calibrator
0103
In Commercial Distribution
0103
LIN-ZHI INTERNATIONAL, INC.
B07601030
HIBCC

1
840839190 *Terms of Use
5mL/bottle. Concentration: 500 ng/mL of Methamphetamine.
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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
Amphetamine/methamphetamine group 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 the amphetamine and/or methamphetamine group(s) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
DLJ Calibrators, Drug Specific
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102210 000
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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

24b137d5-5faa-493a-abac-77fc3468adc3
July 06, 2018
3
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)

[?]
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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