FDA.reportPublic FDA data

TEST1 2.0

Primary DI
08056040148945
Brand
TEST1 2.0
Company
ALIFAX SRL
Model
TEST1 2.0
Catalog number
SI 195.210/THL
Published
2022-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GKBDevice, Automated Sedimentation Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKBDevice, Automated Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056040148945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056040148945080560401489458056040148945

GMDN Terms#

Term, Definition table
TermDefinition
Erthrocyte sedimentation rate (ESR) analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.

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
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
08056040140352ALFRED 60/ASTALFRED 60/ASTSI 105.100/AST2022-10-06
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
08719189137781StarrsedMechatronics USA LLCGKB2024-08-26
00860011967736ZBT-ESRSTERILE SAFEQUIP & CHEMICALS LLPGKB2024-07-09
00868556000208ESR STAT 6Airscan, Inc.GKB2024-06-04
08033891324551VES-MATIC ORIGINALDIESSE DIAGNOSTICA SENESE SPAGKB2023-12-14
00850028040041iSED EliteALCOR SCIENTIFIC INC.GKB2023-11-03
03661540300288Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300202Monosed® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300257Excyte® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300264Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
03661540300271Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
08719189137132Starrsed Cleaning AgentRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137217Starrsed Rinse SolutionRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137224Starrsed X-CleanRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137231Starrsed DisinfectantRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137200Starrsed SalineRR Mechatronics Manufacturing B.V.GKB2023-07-24
06936895301097BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GKB2023-07-05
08719189137118Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137125Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137149Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137170Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137286StarrsedMechatronics USA LLCGKB2022-12-05