FDA.reportPublic FDA data

Excyte®

Primary DI
03661540700446
Brand
Excyte®
Company
ELITechGroup B.V.
Model
DUO-MIX
Published
2016-11-21
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
03661540700446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540700446036615407004463661540700446

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
415733737
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540700064Excyte® Mini2016-11-21
03661540700071Excyte® Mini2016-11-21
03661540700118Excyte® 202016-11-21
03661540700125Excyte® 202016-11-21
03661540600401Selectra ProM6003-4362016-11-18
03661540700606Excyte® ESR Vacuum Tube 2016-11-24
03661540700613Excyte® ESR Non-Vacuum Tube 2016-11-24
03661540700668Excyte® Plastic ESR Vacuum Tube 2016-11-24
03661540700675Excyte® Plastic ESR Vacuum Tube High Altitude 2016-11-24

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
03661540304439ExcyteELITECHGROUP INC.GLE2018-12-26