Acucy Calibration Device

GUDID 00742860100345

SEKISUI DIAGNOSTICS, LLC

Optical instrument calibration/verification reference standard IVD
Primary Device ID00742860100345
NIH Device Record Key387cfaef-aa3e-454a-9492-d23d2a98031d
Commercial Distribution Discontinuation2019-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAcucy Calibration Device
Version Model Number1031
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 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
GS100742860100345 [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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