Acucy System

GUDID 00742860100338

SEKISUI DIAGNOSTICS, LLC

Photometric immunoassay analyser IVD
Primary Device ID00742860100338
NIH Device Record Key87305a6f-26b9-4e80-a161-d64e40b2d6bf
Commercial Distribution Discontinuation2019-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAcucy System
Version Model Number1039
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100742860100338 [Primary]

FDA Product Code

PSZDevices Detecting Influenza A, B, And C Virus Antigens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-02
Device Publish Date2019-09-24

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