FDA.reportPublic FDA data

ALFRED 60/AST

Primary DI
08056040140352
Brand
ALFRED 60/AST
Company
ALIFAX SRL
Model
ALFRED 60/AST
Catalog number
SI 105.100/AST
Published
2022-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JTAMonitor, Microbial Growth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTAMonitor, Microbial GrowthMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056040140352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056040140352080560401403528056040140352

GMDN Terms#

Term, Definition table
TermDefinition
Urine analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435930630
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056040140291ALFRED 60ALFRED 60SI 105.1002022-10-06
08056040140314TEST1 BCLTEST1 BCLSI 195.220/BCL2022-10-06
08056040140321TEST1 YDLTEST1 YDLSI 195.240/YDL2022-10-06
08056040141519TEST1 THLTEST1 THLSI 195.210/THL2022-10-06
08056040141526TEST1 SDLTEST1 SDLSI 195.230/SDL2022-10-06
08056040141533TEST1 XDLTEST1 XDLSI 195.260/XDL2022-10-06
08056040142691TEST1 MDLTEST1 MDLSI 195.250/MDL2022-10-06
08056040144497ROLLER 10 PLUS NEEDLEROLLER 10 PLUS NEEDLESI R10-PN2022-10-06
08056040148778LIGHT SCATTERING TEST KITLIGHT SCATTERING TEST KITSI 805.9102022-10-20
08056040148945TEST1 2.0TEST1 2.0SI 195.210/THL2022-10-13
08056040140024LATEX CONTROLSLATEX CONTROLSSI 305.102-A2022-10-06
08056040140031LATEX CONTROLSLATEX CONTROLSSI 305.302-A2022-10-06
08056040140048LATEX CALIBRATORSLATEX CALIBRATORSSI 305.402-A2022-10-06
08056040140086URO-QUICK SCREENING KITURO-QUICK SCREENING KITSI 390.9002022-10-06
08056040140307HB&L UROQUATTROHB&L UROQUATTROSI 190.3002022-10-06
08056040140338JO-PLUSJO-PLUSSI 804.1002022-10-06
08056040140345ROLLER 20ROLLER 20SI R20-PN2022-10-06
08056040141168POSITIVE CONTROL KITPOSITIVE CONTROL KITSI 190.9112022-10-06
08056040141182AUTOMATION KITAUTOMATION KITSI 1201.9002022-10-06
08056040141212LATEX CONTROLSLATEX CONTROLSSI 305.100-A2022-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336146996cobas® Microbial Inactivation SolutionRoche Diagnostics GmbHJTA2026-03-26
30382902495605BD BACTEC™ Subculturing/Aerobic Venting UnitBECTON, DICKINSON AND COMPANYJTA2024-09-17
60382902495606BD BACTEC™ Subculturing/Aerobic Venting UnitBECTON, DICKINSON AND COMPANYJTA2024-09-17
08056040148778LIGHT SCATTERING TEST KITALIFAX SRLJTA2022-10-20
08056040140086URO-QUICK SCREENING KITALIFAX SRLJTA2022-10-06
08056040140291ALFRED 60ALIFAX SRLJTA2022-10-06
08056040140307HB&L UROQUATTROALIFAX SRLJTA2022-10-06
08056040141168POSITIVE CONTROL KITALIFAX SRLJTA2022-10-06
08056040141182AUTOMATION KITALIFAX SRLJTA2022-10-06
08056040141281URO-QUICK RAA KITALIFAX SRLJTA2022-10-06
08056040141502HB&L UROQUATTRO LIGHTALIFAX SRLJTA2022-10-06
08056040142615RAA BACTERIAL REAGENT PACKALIFAX SRLJTA2022-10-06
00819398026901N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026918N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026925N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026932N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026949N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026956N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026963N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398027168N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398027175N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398021678N/AHARDY DIAGNOSTICSJTA2020-06-02
30382902710562BD BBL™ Venting UnitBECTON, DICKINSON AND COMPANYJTA2018-05-25