DEVICE: LZI Oral Fluid Collectors (B076S0000B1)
Device Identifier (DI) Information
LZI Oral Fluid Collectors
S0000b
In Commercial Distribution
S0000b
LIN-ZHI INTERNATIONAL, INC.
S0000b
In Commercial Distribution
S0000b
LIN-ZHI INTERNATIONAL, INC.
High-density polypropylene (HDPE) 50 mL centrifuge tubes.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
38868 | Drug-testing specimen collection kit IVD |
A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, 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 in vitro diagnostic investigation. This is a single-use device.
|
Active | false |
FDA Product Code
[?]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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131652 | 000 |
K131653 | 000 |
K141205 | 000 |
K141320 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ff6646b8-cff0-4c53-a409-56526607fe64
July 22, 2021
5
July 07, 2016
July 22, 2021
5
July 07, 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:
B076S0000B0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined