BRF for cobas 8100

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+HF FAMILY OF CRT-DS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

C-5 (b1f) RID plate kit

FDA UDI

KENT LABORATORIES INC·B1761105·Radial immunodiffusion plate package for Human ...

Anti Human complement C5 (b1f) FITC

FDA UDI

KENT LABORATORIES INC·B1761102·Fluorescein conjugated polyclonal goat antiseru...

BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

QUANTA LITE ACA IGM (HRP)

FDA 510(k)

FDA Class 2 ·Immunology

Decapinol Oral Rinse

FDA registration

Sigmar Italia S.P.A·1 product·🇮🇹 Italy

ARCOS IMPACTION HANDLE

FDA registration

BRADFORD TOOL GROUP·1 product·🇬🇧 United Kingdom

ARCOS INNER GUIDE TUBE; ARCOS OUTER GUIDE TUBE

FDA registration

BRADFORD TOOL GROUP·1 product·🇬🇧 United Kingdom

ARCOS TARGET SECURING BOLT

FDA registration

BRADFORD TOOL GROUP·1 product·🇬🇧 United Kingdom

ARCOS 3.6MM DRILL

FDA registration

BRADFORD TOOL GROUP·1 product·🇬🇧 United Kingdom

RELI

FDA UDI

MYCO MEDICAL SUPPLIES INC.·00386120007878·REDISORB Undyed Braided & Coated Polyglycolic A...

Single-use Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BTF/BJF STEROID COLLAR

Single use Grasping Forceps BGF

Device

EU MDR · Eu Md Class 1 ·Anrei Medical (HZ) Co., Ltd.·On the market