FDA.reportPublic FDA data

HemoCue® 801 Connect

Primary DI
07311091391681
Brand
HemoCue® 801 Connect
Company
Hemocue AB
Model
139168
Catalog number
139168
Device description
HemoCue® 801 Connect
Published
2019-04-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
07311091391681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07311091391681073110913916817311091391681

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
356164426
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17311091130034HemoCue® WBC Microcuvettes1130031130032016-05-31
07311091230010HemoCue® WBC Analyzer1230011230012016-05-31
17311091118148HemoCue® Hb 301 Microcuvettes1118141118142022-10-28
27311091118077HemoCue® Hb 301 Microcuvettes1118141118142022-10-28
17311091118094HemoCue® Hb 301 Microcuvettes1118091118092020-09-04
17311091118124HemoCue® Hb 301 Microcuvettes1118121118122022-08-30
17311091107050HemoCue® Glucose 201 Microcuvettes1107051107052016-05-31
17311091107067HemoCue® Glucose 201 Microcuvettes1107061107062016-05-31
17311091107234HemoCue® Glucose 201 Microcuvettes1107231107232016-05-27
07311091207067HemoCue® Glucose 201 Analyzer1207061207062016-05-31
07311091207074HemoCue® Glucose 201 Analyzer1207071207072016-05-31
07311091214225HemoCue® Glucose 201 DM Analyzer1214221214222016-05-31
07311091214447HemoCue® Glucose 201 DM Analyzer1214441214442016-05-31
17311091218046HemoCue® Hb301 Analyzer1218041218042016-05-31
27311091118121HemoCue® Hb 301 Microcuvettes1118121118122022-08-30
17311091118070HemoCue® Hb 301 Microcuvettes1118071118072016-12-01
07311091218278HemoCue® Hb301 Analyzer1218271218272020-09-04
07311091118097HemoCue® Hb 301 Microcuvettes1118091118092020-09-04
07311091206237HemoCue® Albumin 201 Analyzer1206231206232019-04-25
17311091106084HemoCue® Urine Albumin Microcuvettes1106081106082019-04-25

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