IMMUCHEM COVALENT COAT SOLID PHASE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RIA FOR TOTAL THYROXINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THYROXINE T4 KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COAT-A-COUNT NEONATAL T4 KIT RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IQ TT4 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RIACOAT T-4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPAC TM T4 RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CDX-2 & CEA Multiplex Cocktail; Clones EP25 & COL-1 (Ready-To-Use) 25 mL

Device

EU IVDR · Eu Ivd Class C ·ScyTek Laboratories Inc.·On the market·1 country

CDX-2 & CEA Multiplex Cocktail; Clones EP25 & COL-1 (Ready-To-Use) 7 mL

Device

EU IVDR · Eu Ivd Class C ·ScyTek Laboratories Inc.·On the market·1 country

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent, Identity ADx XL, Sustain XL, Verity ADx XL, Victory XL, and Zephyr XL

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

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav MiFi Open-Irrigated Ablation Catheter

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) Assay

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX FAMILY OF PACEMAKERS SYNCHRONCY DEVICE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·INDENTITY & IDENTITY ADX FAMILY OF DEVICES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)