ACCESS HIV Ag/Ab combo QC C39452

GUDID 15099590745172

The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV Ag/Ab combo QC is for use on the DxI 9000 Access Immunoassay Analyzer.

Beckman Coulter, Inc.

HIV1/HIV2 antigen/antibody IVD, control
Primary Device ID15099590745172
NIH Device Record Key60e1145e-1536-425c-9c25-621cb1a17c05
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCESS HIV Ag/Ab combo QC
Version Model NumberC39452
Catalog NumberC39452
Company DUNS008254708
Company NameBeckman Coulter, Inc.
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 Datetrue
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
GS115099590745172 [Primary]

FDA Product Code

MJYKit, Serological, Negative Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-25
Device Publish Date2024-03-15

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