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QC Sets and Panels: Helix Elite™

FDA UDI
MICROBIOLOGICS INC.·70845357041219·Assayed GBS LB Control Panel

QC Sets and Panels: Helix Elite™

FDA UDI
MICROBIOLOGICS INC.·70845357041240·Assayed Respiratory Control Panel

QC Sets and Panels: Helix Elite™

FDA UDI
MICROBIOLOGICS INC.·70845357041080·BD MAX™ CT/GC/TV 20-Day QC Panel

Amplichek

FDA UDI
BIO-RAD LABORATORIES, INC.·00847661005933·Amplichek II Level 1 (A nucleic acid control.)

SPOTFIRE RSP Negative Control

FDA UDI
Mmqci·00852720008107·NEG external qc to monitor the performance of i...

FilmArray RP EZ Control Panel M265

FDA UDI
Mmqci·00852720008046·External quality controls to monitor the perfor...

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona

THD N-ANO DIGITAL (TR)

Basic UDI-DI
EU MDR · Eu Md Class 1 ·THD S.P.A.·4 devices

Cervista

FDA UDI
Hologic, Inc.·15420045500143·

HLA-A SSP Kit

FDA UDI
Bio-Rad Medical Diagnostics GmbH·07611969953257·for 24 determinations of HLA-A alleles; For In ...

DRB SSP Kit

FDA UDI
Bio-Rad Medical Diagnostics GmbH·07611969953288·Kit for 24 determinations of HLA-DRB alleles; F...

cobas®4800 HPV Controls Kit

FDA UDI
Roche Molecular Systems, Inc.·00875197003222·

Aptima

FDA UDI
Hologic, Inc.·15420045500051·

cobas®4800 System Liquid Cytology Preparation Kit

FDA UDI
Roche Molecular Systems, Inc.·00875197003192·

HPV-HR

FDA UDI
Hologic, Inc.·15420045504271·

cobas® 4800 System Sample Preparation Kit

FDA UDI
Roche Molecular Systems, Inc.·00875197003185·

cobas® 4800 HPV Amplification/Detection Kit

FDA UDI
Roche Molecular Systems, Inc.·00875197003260·

HLA-B SSP Kit

FDA UDI
Bio-Rad Medical Diagnostics GmbH·07611969953264·for 24 determinations of HLA-B alleles; For In ...

cobas® 4800 System Wash Buffer Kit

FDA UDI
Roche Molecular Systems, Inc.·00875197003246·

HLA-C SSP Kit

FDA UDI
Bio-Rad Medical Diagnostics GmbH·07611969953271·Kit for 24 determinations of HLA-C alleles; For...