AU

GUDID 15099590010591

α-1 Acidglycoprotein

BECKMAN COULTER IRELAND INC.

Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Primary Device ID15099590010591
NIH Device Record Key2eb90dd3-8efc-487a-8560-afa469f77edd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAU
Version Model NumberOSR6162
Company DUNS985071975
Company NameBECKMAN COULTER IRELAND INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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
GS115099590010591 [Primary]

FDA Product Code

LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [AU]

15099590666361Urine CSF Albumin Calibrator
15099590635602Lyophilized Chemistry Calibrator Level 1
15099590635572Lyophilized Chemistry Calibrator Level 2
15099590131180SYSTEM CALIBRATOR
15099590070441BICARBONATE CALIBRATOR
15099590012120HbA1c Advanced
15099590010645MICROALBUMIN
15099590010607α-1 ANTITRYPSIN
15099590010591α-1 Acidglycoprotein

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