EasySampler D-Xylose Kit QT04203

GUDID 00850010197067

EasySampler D-xylose Kit, 10T

QUINTRON INSTRUMENT COMPANY, INC.

Breath specimen container IVD
Primary Device ID00850010197067
NIH Device Record Keyfc0dfbd4-ef3a-49b4-a919-1a26f0f87b36
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasySampler D-Xylose Kit
Version Model NumberQT04203
Catalog NumberQT04203
Company DUNS874498744
Company NameQUINTRON INSTRUMENT COMPANY, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010197067 [Primary]

FDA Product Code

NNIContainer, Specimen, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

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