DEVICE: LZI Oral Fluid Collectors (B076S0000B1)

Device Identifier (DI) Information

LZI Oral Fluid Collectors
S0000b
In Commercial Distribution
S0000b
LIN-ZHI INTERNATIONAL, INC.
B076S0000B1
HIBCC

50
840839190 *Terms of Use
High-density polypropylene (HDPE) 50 mL centrifuge tubes.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Drug-testing specimen collection kit IVD A covered receptacle and other associated materials/tools, available either [non-prescription] over-the-counter and/or to health professionals, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other investigation. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LAS Drug Specific Control Materials
DLJ Calibrators, Drug Specific
LAF Gas Chromatography, Methamphetamine
DKZ Enzyme Immunoassay, Amphetamine
DJG Enzyme Immunoassay, Opiates
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ff6646b8-cff0-4c53-a409-56526607fe64
March 29, 2018
2
July 07, 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: B076S0000B0 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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