FDA.reportPublic FDA data

LATEX CONTROLS

Primary DI
08056040141212
Brand
LATEX CONTROLS
Company
ALIFAX SRL
Model
LATEX CONTROLS
Catalog number
SI 305.100-A
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
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
08056040141212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056040141212080560401412128056040141212

GMDN Terms#

Term, Definition table
TermDefinition
Erythrocyte sedimentation rate (ESR) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435930630
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration 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
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

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