FDA.reportPublic FDA data

Test Tubes, Macro

Primary DI
G0561003361
Brand
Test Tubes, Macro
Company
Bio/Data Corporation
Model
100336
Catalog number
100336
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
G0561003361PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051392959
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0561076501AGG/PAK 5 Combo Kit1076501076502024-10-01
G0561059771Stir Bars, Macro1059771059772023-08-30
G0561059901Stir Bars, Micro1059901059902023-08-30
G0561009890Calcium Chloride10098910099892023-08-30
G0561009910Tris Buffered Saline1009911009912023-08-30
G0561009940Sodium Citrate1009941009942023-08-30
G0561013751Profiler Paper1013751013752023-08-30
G0561015211Test Tubes, Micro1015211015212023-08-30
G0561055981Printer Paper1055981055982023-08-30
G0561060771Platelet Aggregometer ProfilerPAP-8E1060772023-08-30
G0561068421PDQ Platelet Centrifuge1068421068422023-08-30
G0561068521Transfer Pipettes, Disposable1068521068522023-08-30
G0561068531Sample Tubes1068531068532023-08-30
G0561068991Sample Tube Caps1068991068992023-08-30
G0561071170LTA Check Test Kit1071171071172023-08-30
G0561071461MagneTube1071461071462023-08-30
G0561071490LTA Check CD1071491071492023-08-30
G0561071530PAP-8E Software CD1071531070532023-08-30
G0561060751Platelet Aggregometer ProfilerPAP8E1060752022-03-23
G0561013101PAR/PAK II1013101013102022-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03661540700446Excyte® ELITechGroup B.V.GLE2016-11-21