DC-CAL Calibrator SE-035

GUDID 00628063400447

SEKISUI DIAGNOSTICS, LLC

Multiple clinical chemistry analyte IVD, calibrator
Primary Device ID00628063400447
NIH Device Record Key9df5d529-0310-4fdf-a904-f3ce6d5f2bbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameDC-CAL Calibrator
Version Model NumberSE-035
Catalog NumberSE-035
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count5
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
GS100628063400447 [Primary]
GS110628063400444 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIXCALIBRATOR, MULTI-ANALYTE MIXTURE

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

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

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10742860100397 - OSOM ULTRA PLUS FLU A&B Test 2022-06-10
00628063401222 - DC-TROL LEVELS 1 & 22020-04-07
00628063400003 - Carbon Dioxide L3K2019-10-21
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