FDA.reportPublic FDA data

RALS

Primary DI
00850049633123
Brand
RALS
Company
Abbott Rapid Diagnostics Informatics, Inc.
Model
8.1.0
Catalog number
8.1.0
Device description
RALS test results capturing and data transferring software
Published
2024-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049633123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049633123008500496331238500496331230850049633123

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)627-7257rals.support@abbott.com

Regulatory Flags#

DUNS number
938910791
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049633253RALS8.4.18.4.12024-10-30
00850049633246RALS8.4.08.4.02024-10-04
00850049633239RALS8.3.08.3.02024-07-19
00850049633161RALS8.2.08.2.02024-04-12
00850049633208RALS7.1.37.1.32024-04-08
00850049633017RALS6.0 SP9 Patch 26.0 SP9 Patch 22024-03-04
00850049633024RALS7.1.17.1.12024-03-04
00850049633031RALS7.1.27.1.22024-03-04
00850049633109RALS8.0.18.0.12024-02-26
00850049633130RALS8.1.18.1.12024-02-26
00850049633055RALS8.0.08.0.02023-07-01
00850049633048RALS7.1.57.1.52023-06-05
00850049633000RALS7.1.47.1.42023-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142373012SoftPathSCC SOFT COMPUTERJQP2026-05-29
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04