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

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...

T2Bacteria Panel

FDA registration

T2 BIOSYSTEMS, INC.·2 products·🇺🇸 United States

LIAISON PLEX Yeast Blood Culture Assay

FDA registration

Luminex Corporation·2 products·🇺🇸 United States

Xpert Xpress MVP

FDA registration

CEPHEID·2 products·🇺🇸 United States

Aptima SARS-CoV-2 Assay

FDA registration

HOLOGIC, LTD.·2 products·🇬🇧 United Kingdom

Aptima Neisseria gonorrhoeae Assay

FDA registration

Hologic, Inc.·2 products·🇺🇸 United States