DC-TROL LEVELS 1 & 2

GUDID 00628063401222

SEKISUI DIAGNOSTICS, LLC

Multiple clinical chemistry analyte IVD, control
Primary Device ID00628063401222
NIH Device Record Key8e819724-7edb-4cde-b9ec-454c57a640e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDC-TROL LEVELS 1 & 2
Version Model NumberSM-057
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100628063401222 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-07
Device Publish Date2020-03-30

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

00628063401291 - Acetaminophen2023-05-16
00628063401307 - Acetaminophen Calibrator2023-05-16
00628063401314 - Alinity c Acetaminophen2023-05-16
00628063401321 - Alinity c Acetaminophen Calibrator2023-05-16
10742860100397 - OSOM ULTRA PLUS FLU A&B Test 2022-06-10
00628063401222 - DC-TROL LEVELS 1 & 22020-04-07
00628063401222 - DC-TROL LEVELS 1 & 22020-04-07
00628063400003 - Carbon Dioxide L3K2019-10-21
00628063400287 - CARBON DIOXIDE L3K Assay2019-10-21

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