CREATININE-S Assay 221-30

GUDID 00628063400409

SEKISUI DIAGNOSTICS, LLC

Creatinine IVD, kit, spectrophotometry
Primary Device ID00628063400409
NIH Device Record Key1a57706a-7fd4-456c-ba2f-a092b2d00b5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCREATININE-S Assay
Version Model Number221-30
Catalog Number221-30
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
GS100628063400409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGXALKALINE PICRATE, COLORIMETRY, CREATININE

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 [CREATININE-S Assay]

00628063400416221-50
00628063400409221-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.