CARBON DIOXIDE L3K-C Assay 288-80

GUDID 00628063400348

SEKISUI DIAGNOSTICS, LLC

Carbon dioxide (CO2) IVD, kit, spectrophotometry
Primary Device ID00628063400348
NIH Device Record Key21fb464a-4ab1-4104-b24f-59346cc939ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBON DIOXIDE L3K-C Assay
Version Model Number288-80
Catalog Number288-80
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628063400348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHSENZYMATIC, CARBON-DIOXIDE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [CARBON DIOXIDE L3K-C Assay]

00628063400348288-80
00628063400331288-36

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