Microalbumin SK252-20

GUDID 00628063401116

SEKISUI DIAGNOSTICS, LLC

Microalbumin IVD, kit, nephelometry/turbidimetry
Primary Device ID00628063401116
NIH Device Record Key8b137e01-43ad-4f4b-9cd3-8915bb2a649a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroalbumin
Version Model NumberSK252-20
Catalog NumberSK252-20
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
GS100628063401116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCFALBUMIN, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-10
Device Publish Date2019-10-02

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