FDA.reportPublic FDA data

ROMA

Primary DI
00869164000024
Brand
ROMA
Company
Fujirebio Diagnostics, Inc.
Model
404-10US
Device description
ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160090000Lumipulse G ROMAFujirebio Diagnostics,Inc.2016-05-16ONX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869164000024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869164000024008691640000248691640000240869164000024

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999xx@xx.xxx

Regulatory Flags#

DUNS number
048524263
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio CL00732024-11-04
00850212007041Beckman Coulter PK TP System Control SetPH35022016-09-16
00850212007058Beckman Coulter PK CMV-PA SYSTEM Control Set240226PA23022016-09-16
00869164000055Serodia TP-PA Kits2349522023-12-06
00869164000062Serodia TP-PA Kits2349762023-12-06
00869164000079Emit Cyclosporine Sample40080862023-12-06
00869164000000MESOMARK801-9052014-09-17
00869164000048Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator ToolCL00122022-11-10
00850212007096Lumipulse G Wash Solution40082482017-10-06
00869164000017Lumipulse G ROMACL00042016-09-19
00850212007072Fertility Control 21301622020-12-07
00850212007089Vitamin D Control21301662020-07-14
00850212007003FITC Anti-Rabies Monoclonal Globulin800-0922016-09-16
00850212007010Serodia TP-PA16262016-09-16
00850212007027Serodia TP-PA16332016-09-16
00850212007034Vitamin D Control21301522016-09-16
00850212007065Syphilis Control21301702017-06-23

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
00380740138738ARCHITECTABBOTT LABORATORIESONX2016-09-09