FDA.reportPublic FDA data

BG Analytics Software

Primary DI
00862696000289
Brand
BG Analytics Software
Company
ASSOCIATES OF CAPE COD, INC.
Model
0
Device description
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
Published
2020-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00862696000289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862696000289008626960002898626960002890862696000289

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

Regulatory Flags#

DUNS number
076574078
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862696000227Fungitell STAT12020-09-01
00862696000210Fungitell®FT001FT0012018-06-29
00862696000203Fungitell®FT001FT0012016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374941SoftBiochemistrySCC SOFT COMPUTERJQP2026-10-16
00810142374958SoftCytogeneticsSCC SOFT COMPUTERJQP2026-10-16
00810142374965SoftPathDxSCC SOFT COMPUTERJQP2026-10-16
00810142374972SoftFlowCytometrySCC SOFT COMPUTERJQP2026-10-16
00810142374989SoftHLASCC SOFT COMPUTERJQP2026-10-16
00810142374996SoftMolecularSCC SOFT COMPUTERJQP2026-10-16
00810142375009SoftGenomicsSCC SOFT COMPUTERJQP2026-10-16
00810142375016SoftTrackSCC SOFT COMPUTERJQP2026-10-16
00810142374071SoftTotalQCSCC SOFT COMPUTERJQP2026-10-07
00810142373456SoftLabSCC SOFT COMPUTERJQP2026-09-29
00810142373463SoftMicSCC SOFT COMPUTERJQP2026-09-29
B236CATL202520Clinisys AtlasCliniSys, IncJQP2026-09-29
00380740225384AlinIQABBOTT SRLJQP2026-09-28
00810142374378SoftBiochemistrySCC SOFT COMPUTERJQP2026-08-26
00810142374385SoftCytogeneticsSCC SOFT COMPUTERJQP2026-08-26
00810142374392SoftPathDxSCC SOFT COMPUTERJQP2026-08-26
00810142374408SoftFlowCytometrySCC SOFT COMPUTERJQP2026-08-26
00810142374415SoftHLASCC SOFT COMPUTERJQP2026-08-26
00810142374422SoftMolecularSCC SOFT COMPUTERJQP2026-08-26
00810142374439SoftGenomicsSCC SOFT COMPUTERJQP2026-08-26
00810142374446SoftTrackSCC SOFT COMPUTERJQP2026-08-26
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