TOTAL PROTEIN SK201-10

GUDID 00628063400881

SEKISUI DIAGNOSTICS, LLC

Total protein IVD, kit, enzyme spectrophotometry
Primary Device ID00628063400881
NIH Device Record Key91fb3e83-c416-4b02-88b0-c2b9038c9938
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOTAL PROTEIN
Version Model NumberSK201-10
Catalog NumberSK201-10
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count2
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
GS100628063400881 [Primary]
GS110628063400888 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

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

On-Brand Devices [TOTAL PROTEIN]

00628063400881SK201-10
00628063400874200-55

Trademark Results [TOTAL PROTEIN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOTAL PROTEIN
TOTAL PROTEIN
85826834 4515897 Live/Registered
Jay Cutler Elite, LLC
2013-01-18

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