Creatine Kinase Assay SK326-20

GUDID 00628063401079

SEKISUI DIAGNOSTICS, LLC

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Primary Device ID00628063401079
NIH Device Record Key00b0669e-d209-40aa-a828-6d29a556e893
Commercial Distribution StatusIn Commercial Distribution
Brand NameCreatine Kinase Assay
Version Model NumberSK326-20
Catalog NumberSK326-20
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
GS100628063401079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGSNAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

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