MicroScan PROMPT

GUDID 15099590659561

Inoculation System-D

Beckman Coulter, Inc.

General-microorganism antimicrobial susceptibility culture medium IVD
Primary Device ID15099590659561
NIH Device Record Key14a1eb3d-dd49-42f9-82e2-fcdac768e8bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroScan PROMPT
Version Model NumberB1026-10D
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count60
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105099590659564 [Unit of Use]
GS115099590659561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIEReagent/Device, Inoculum Calibration

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Beckman Coulter, Inc.

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15099590760830 - ACCESS NT-proBNP CALIBRATORS2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te
15099590772840 - Access Ferritin2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti

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