CHOLESTEROL SK234-10

GUDID 00628063400379

SEKISUI DIAGNOSTICS, LLC

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Primary Device ID	00628063400379
NIH Device Record Key	fd7b1ed3-a9f4-4eff-b013-a639359a306a
Commercial Distribution Status	In Commercial Distribution
Brand Name	CHOLESTEROL
Version Model Number	SK234-10
Catalog Number	SK234-10
Company DUNS	966812344
Company Name	SEKISUI DIAGNOSTICS, LLC
Device Count	2
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628063400379 [Primary]
GS1	10628063400376 [Unit of Use]

FDA Product Code

CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-09-20

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Trademark Results [CHOLESTEROL]

Mark Image Registration \| Serial	Company Trademark Application Date
CHOLESTEROL 73837165 1611220 Dead/Cancelled	KSF MEDICAL PUBLISHING COMPANY, INC. 1989-11-09
CHOLESTEROL 73783518 not registered Dead/Abandoned	DAWN FOOD PRODUCTS, INC. 1989-02-27