T2Dx®

FDA UDI

T2 BIOSYSTEMS, INC.·M70870049330·Instrument is a multiplex instrument that uses ...

I-UNICELL Incubator

FDA UDI

Shenzhen YHLO Biotech Co., Ltd.·06925912711049·

Solana

FDA UDI

QUIDEL CORPORATION·30014613202783·Solana instrument

iC-Reader

FDA UDI

ICUBATE, INC·B769ICRADAA00000·The iC-System is an in vitro diagnostic device ...

SureScan Dx Microarray Scanner

FDA UDI

AGILENT TECHNOLOGIES SINGAPORE PTE LTD·05700571108703·SureScan Dx Microarray Scanner

Nano-CheckTM Dengue NS1

FDA UDI

NANO-DITECH CORPORATION·00895160002472·An in vitro diagnostic test for the detection o...

FilmArray® 2.0 Instrument

FDA UDI

BIOFIRE DIAGNOSTICS, LLC·00815381020048·Refurbished IVD Instrument (FilmArray® 2.0 Inst...

7500 Fast Dx Real-Time PCR  Instrument

FDA UDI

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302000222·

BIOFIRE ® SPOTFIRE ® Module

FDA UDI

BIOFIRE DIAGNOSTICS, LLC·00815381020369·IVD Instrument (SPOTFIRE ® Module).

OpsisDx

FDA UDI

ENTOPSIS, LLC·B550ENT0100·Metal tray used for quality control of OpsisDx ...

FilmArray® 2.0 Instrument NGDS Configuration

FDA UDI

BIOFIRE DEFENSE, LLC·00851458005143·NGDS FilmArray Configuration kit (no computer i...

Opus

FDA UDI

BIO-RAD LABORATORIES, INC.·03610522260829·CFX Opus Deepwell Dx

nCounter Prep Station 5s

FDA UDI

NANOSTRING TECHNOLOGIES, INC.·00859812006065·The Prep Station is a part of the nCounter DX A...

Affymetrix

FDA UDI

AFFYMETRIX, INC.·00856826006036·GeneChip Scanner GCS 3000Dx v.2

BioPlex 2200

FDA UDI

BIO-RAD LABORATORIES, INC.·03610520505915·BioPlex 2200 System Operation Manual , Software...

MAGPIX® Drive Fluid

FDA UDI

LUMINEX CORPORATION·00840487101421·The MAGPIX Drive Fluid serves as the delivery m...

MAGPIX® Performance Verification Kit

FDA UDI

LUMINEX CORPORATION·00840487100288·The Luminex MAGPIX Performance Verification Kit...

Controller, Full/Swipe

FDA UDI

C2 THERAPEUTICS, INC.·00854924006064·Controller for Full and Swipe C2 CryoBalloon Ab...

C2 CryoBalloon Focal Controller

FDA UDI

C2 THERAPEUTICS, INC.·00854924006125·C2 CryoBalloon Focal Controller for C2 CryoBall...

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L