Wide Range CRP Multi-Calibrators SE-250

GUDID 00628063401017

SEKISUI DIAGNOSTICS, LLC

C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator C-reactive protein (CRP) IVD, calibrator
Primary Device ID00628063401017
NIH Device Record Key35838e3d-b1a4-479c-b653-bd39a628f332
Commercial Distribution StatusIn Commercial Distribution
Brand NameWide Range CRP Multi-Calibrators
Version Model NumberSE-250
Catalog NumberSE-250
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
GS100628063401017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JITCALIBRATOR, SECONDARY

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 Date2016-09-20

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