Home GUDID 00380740138738 ARCHITECT
Primary DI 00380740138738
Brand ARCHITECT
Company ABBOTT LABORATORIES
Model 6P30-21
Catalog number 06P3021
Device description ARCHITECT ROMA
Published 2016-09-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ONX ovarian adnexal mass assessment score test system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ONX Ovarian Adnexal Mass Assessment Score Test System Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740138738 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00380740138738 00380740138738 380740138738 0380740138738
GMDN Terms# Term, Definition table Term Definition Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method.
Regulatory Flags# DUNS number 079226220 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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