FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONXovarian adnexal mass assessment score test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONXOvarian Adnexal Mass Assessment Score Test SystemObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740138738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740138738003807401387383807401387380380740138738

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740017460ARCHITECT8K28-0208K28022016-06-06
00380740017477ARCHITECT8K28-1108K28112016-06-06
00380740017484ARCHITECT8K28-2708K28272016-06-06
00380740017491ARCHITECT8K28-3508K28352016-06-06
00380740081911ARCHITECT1P06-0201P06022016-09-09
00380740019730ARCHITECT9D96-2109D96212016-06-06
00380740225742ARCHITECT08G983008G98302026-10-14
00380740225759ARCHITECT04J623004J62302026-10-14
00380740019747ARCHITECT9D97-2109D97212016-06-06
00380740000202ARCHITECT1E01-2101E01212016-06-06
00380740019761ARCHITECT9D99-2109D99212016-06-06
00380740225575ARCHITECT04P553104P55312026-08-22
00380740138783Alinity09P710109P71012023-11-16
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860942000106OveraAspira Women's Health Inc.ONX2022-11-23
00380740146269AlinityAbbott GmbHONX2020-08-10
00860942000113OVA1Aspira Women's Health Inc.ONX2018-01-15
00365702702127ROMA Calculation Tool Using Elecsys AssayRoche Diagnostics GmbHONX2016-10-28
00869164000017Lumipulse G ROMAFujirebio Diagnostics, Inc.ONX2016-09-19
00869164000024ROMAFujirebio Diagnostics, Inc.ONX2016-09-19