DC-TROL Level 2 SM-056

GUDID 00628063400461

SEKISUI DIAGNOSTICS, LLC

Multiple clinical chemistry analyte IVD, control
Primary Device ID00628063400461
NIH Device Record Key2af18858-ff44-4a7e-8ea5-9d9adf5334c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDC-TROL Level 2
Version Model NumberSM-056
Catalog NumberSM-056
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count10
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
GS100628063400461 [Primary]
GS110628063400468 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)

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

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
00628063400003 - Carbon Dioxide L3K2019-10-21
00628063400287 - CARBON DIOXIDE L3K Assay2019-10-21

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