FDA.reportPublic FDA data

RALS

Primary DI
00850049633246
Brand
RALS
Company
Abbott Rapid Diagnostics Informatics, Inc.
Model
8.4.0
Catalog number
8.4.0
Device description
RALS test results capturing and data transferring software
Published
2024-10-04
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
00850049633246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049633246008500496332468500496332460850049633246

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
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
00850049633123RALS8.1.08.1.02024-02-26
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
00810142374453SoftBiochemistrySCC SOFT COMPUTERJQP2026-07-14
00810142374460SoftCytogeneticsSCC SOFT COMPUTERJQP2026-07-14
00810142374477SoftPathDxSCC SOFT COMPUTERJQP2026-07-14
00810142374484SoftFlowCytometrySCC SOFT COMPUTERJQP2026-07-14
00810142374491SoftHLASCC SOFT COMPUTERJQP2026-07-14
00810142374507SoftMolecularSCC SOFT COMPUTERJQP2026-07-14
00810142374514SoftGenomicsSCC SOFT COMPUTERJQP2026-07-14
00810142374521SoftTrackSCC SOFT COMPUTERJQP2026-07-14
00810142374279SoftBiobankSCC SOFT COMPUTERJQP2026-07-07
00810142373814SoftTotalQCSCC SOFT COMPUTERJQP2026-07-03
00810142373791SoftGenePortalSCC SOFT COMPUTERJQP2026-06-13
00810142373869SoftBiochemistrySCC SOFT COMPUTERJQP2026-06-10
00810142373876SoftCytogeneticsSCC SOFT COMPUTERJQP2026-06-10
00810142373883SoftPathDxSCC SOFT COMPUTERJQP2026-06-10
00810142373890SoftFlowCytometrySCC SOFT COMPUTERJQP2026-06-10
00810142373906SoftHLASCC SOFT COMPUTERJQP2026-06-10
00810142373920SoftMolecularSCC SOFT COMPUTERJQP2026-06-10
00810142373937SoftGenomicsSCC SOFT COMPUTERJQP2026-06-10
00810142373944SoftTrackSCC SOFT COMPUTERJQP2026-06-10
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