FDA.reportPublic FDA data

Assay container IVD, single-use

Definition
A non-sterile 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.
GUDID devices
57
Last updated
2020-10-05 06:30:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00842768028915Dimension Vista® Small Sample Container (SSC)Siemens Healthcare Diagnostics Inc.104720992020-09-24
00630414221571ADVIA Centaur® Sample CupsSiemens Healthcare Diagnostics Inc.103095452020-09-24
00842768005886Dimension® Flex® reagent cartridge EMPTYSiemens Healthcare Diagnostics Inc.104450392020-09-24
00842768005893Dimension® Dimension Vista® Sample CupsSiemens Healthcare Diagnostics Inc.104450412020-09-24
00842768005909Dimension® Small Sample Container (SSC)Siemens Healthcare Diagnostics Inc.104450402020-09-24
00842768015656Dimension Vista® Flex® reagent cartridge EMPTYSiemens Healthcare Diagnostics Inc.104452182020-09-24
00842768016295Dimension Vista® Empty Vials KitSiemens Healthcare Diagnostics Inc.104452132020-09-24
05700571101032Artisan User Fillable Dispenser #1AGILENT TECHNOLOGIES, INC.AR1852020-09-17
05700571112465User-Fillable Reagent Bottle 5mL Capacity (Link)Dako North America, Inc.SK2002020-09-17
05700571112472User-Fillable Reagent Bottle 12mL Capacity (Link)Dako North America, Inc.SK2012020-09-17
05700571112489User-Fillable Reagent Bottle 25mL Capacity (Link)Dako North America, Inc.SK2022020-09-17
05700571112496User-Fillable Reagent Bottle 50mL Capacity (Link)Dako North America, Inc.SK2032020-09-17
00875197006247cobas&#x00AE prime User Workflow Reagent BottleRoche Molecular Systems, Inc.084604261902020-07-01
00615233002778Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8610-K0502020-05-08
00615233002792Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8617-G0502020-05-08
00840095606288Globe ScientificGLOBE SCIENTIFIC INC.51052019-11-26
00840095606301Globe ScientificGLOBE SCIENTIFIC INC.51062019-11-26
00840095607643Globe ScientificGLOBE SCIENTIFIC INC.55042019-11-26
00840095607667Globe ScientificGLOBE SCIENTIFIC INC.55052019-11-26
00840095607681Globe ScientificGLOBE SCIENTIFIC INC.55102019-11-26
00840095607704Globe ScientificGLOBE SCIENTIFIC INC.55122019-11-26
00840095607728Globe ScientificGLOBE SCIENTIFIC INC.55202019-11-26
00840095607742Globe ScientificGLOBE SCIENTIFIC INC.55212019-11-26
00840095607766Globe ScientificGLOBE SCIENTIFIC INC.55302019-11-26
00840095607780Globe ScientificGLOBE SCIENTIFIC INC.55312019-11-26
00840095607803Globe ScientificGLOBE SCIENTIFIC INC.55352019-11-26
00840095607827Globe ScientificGLOBE SCIENTIFIC INC.55362019-11-26
00840095607889Globe ScientificGLOBE SCIENTIFIC INC.55412019-11-26
00840095607902Globe ScientificGLOBE SCIENTIFIC INC.55422019-11-26
00840095607926Globe ScientificGLOBE SCIENTIFIC INC.55452019-11-26
00840095607940Globe ScientificGLOBE SCIENTIFIC INC.55482019-11-26
00840095607964Globe ScientificGLOBE SCIENTIFIC INC.55502019-11-26
00840095607988Globe ScientificGLOBE SCIENTIFIC INC.55522019-11-26
00840095608008Globe ScientificGLOBE SCIENTIFIC INC.55742019-11-26
00840095608114Globe ScientificGLOBE SCIENTIFIC INC.6500B2019-11-26
00840095608138Globe ScientificGLOBE SCIENTIFIC INC.6500C2019-11-26
00840095608152Globe ScientificGLOBE SCIENTIFIC INC.6500G2019-11-26
00840095608176Globe ScientificGLOBE SCIENTIFIC INC.6500R2019-11-26
00840095608190Globe ScientificGLOBE SCIENTIFIC INC.6500Y2019-11-26
00840095608367Globe ScientificGLOBE SCIENTIFIC INC.68012019-11-26
00380740129613AlinityABBOTT LABORATORIES03R01012019-07-26
00840095600040Globe ScientificGLOBE SCIENTIFIC INC.1070472019-11-27
00840095600828Globe ScientificGLOBE SCIENTIFIC INC.1100212019-11-27
00840095600842Globe ScientificGLOBE SCIENTIFIC INC.1106102019-11-27
00840095600873Globe ScientificGLOBE SCIENTIFIC INC.1106212019-11-27
00840095600897Globe ScientificGLOBE SCIENTIFIC INC.110621NL2019-11-27
00840095600910Globe ScientificGLOBE SCIENTIFIC INC.1107112019-11-27
00840095600934Globe ScientificGLOBE SCIENTIFIC INC.1108112019-11-27
00840095600958Globe ScientificGLOBE SCIENTIFIC INC.110811NL2019-11-27
00840095600972Globe ScientificGLOBE SCIENTIFIC INC.1109112019-11-27
00840095601009Globe ScientificGLOBE SCIENTIFIC INC.110911C2019-11-27
00840095601023Globe ScientificGLOBE SCIENTIFIC INC.1109132019-11-27
00840095601054Globe ScientificGLOBE SCIENTIFIC INC.1109152019-11-27
00884999006515m2000ABBOTT MOLECULAR INC.04J71-602016-09-01
30884999046475m2000ABBOTT MOLECULAR INC.04J71-202016-09-01
30884999046482m2000ABBOTT MOLECULAR INC.04J71-802016-09-01
00630414482279ADVIA® Chemistry Sample CupsSiemens Healthcare Diagnostics Inc.103094502018-09-24