FDA.reportPublic FDA data

Excyte

Primary DI
03661540304439
Brand
Excyte
Company
ELITECHGROUP INC.
Model
Duo-Mix
Catalog number
EX-10573
Device description
Multifunctional mixer for biological liquids
Published
2018-12-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GLEMixer, Blood Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLEMixer, Blood TubeClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540304439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540304439036615403044393661540304439

GMDN Terms#

Term, Definition table
TermDefinition
Blood tube mixer IVDAn electrically-powered laboratory instrument intended to be used for the mixing of blood or other biological fluids contained in blood tubes or other similar specimen receptacles using continuous motion or agitation. It is typically used to provide movement that will prevent the blood from coagulating and/or to agitate the blood with movement for mixing with other solutions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
052423787
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540300400Macroduct Advanced Sweat Collection SystemModel 3710-Sys2025-02-27
03661540304156Potassium Electrode279-001279-0012023-10-01
03661540304163Chloride Electrode280-001280-0012023-10-01
03661540304170Carbon Dioxide Electrode275-001275-0012023-10-01
03661540304187Sodium Electrode278-001278-0012023-10-01
03661540300288Monosed® ESR Vacuum Tubes, CartonPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonEX-50100EX-501002023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonEX-50205EX-502052023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonEP-10605EP-106052023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonEP-10605-H1EP-10605-H12023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerPRD-MSS-EL-08TKNEPRD-MSS-EL-08TKNE2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerPRD-X20-EL-08TKNEPRD-X20-EL-08TKNE2023-10-01
03661540300202Monosed® ESR Vacuum TubesPRD-PRV11B-50PRD-PRV11B-502023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonPRD-PRV11V-H12PRD-PRV11V-H122023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesEX-50100EX-501002023-10-01
03661540300257Excyte® ESR Vacuum TubesEX-50205EX-502052023-10-01
03661540300264Excyte® ESR Vacuum TubeEP-10605EP-106052023-10-01
03661540300271Excyte® ESR Vacuum TubeEP-10605-H1EP-10605-H12023-10-01
03661540304286Direct A1c Control Kit55136551362023-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G0561003361Test Tubes, MacroBio/Data CorporationGLE2023-08-30
G0561015211Test Tubes, MicroBio/Data CorporationGLE2023-08-30
G0561068531Sample TubesBio/Data CorporationGLE2023-08-30
G0561068991Sample Tube CapsBio/Data CorporationGLE2023-08-30
04038917101974Sarmix®M2000,100-240V no rotorSarstedt Aktiengesellschaft & Co.KGGLE2022-11-30
04038917102193SARMIX®,GM1, 115VSarstedt Aktiengesellschaft & Co.KGGLE2022-11-30
04038917141154Tube- Stripper AST-2Sarstedt Aktiengesellschaft & Co.KGGLE2022-11-30
04038917258869Tube-Stripper AST-2SSarstedt Aktiengesellschaft & Co.KGGLE2022-11-30
00304040043387Henry ScheinHENRY SCHEIN, INC.GLE2022-05-03
00664816000151LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816001387LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816001585LW Scientific, Inc,LW SCIENTIFIC, INC.GLE2021-04-08
00664816003299LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816003800LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816003794LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2020-10-22
03661540700446Excyte® ELITechGroup B.V.GLE2016-11-21