Catalog Number

S0000b

Brand Name

LZI Oral Fluid Collectors

Version/Model Number

S0000b

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141320,K141205,K131653,K131652,K131652,K131653,K141205,K141320

Product Code

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

ff6646b8-cff0-4c53-a409-56526607fe64

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

July 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-