OC-Auto Sampling Bottle 3

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·8 devices

OC-Light™ S FIT Sampling Bottles

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ MTBC Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

OC-FCa Reagent Family

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·6 devices

OC-SENSOR Reagent Family

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·14 devices

OC-Light™ S FIT Test Strips

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ Malaria Pv Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ Malaria Pf Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ Malaria Pan Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·2 devices

OC Equipment Family

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·2 devices

14277-2019-CE-IND-NA-PS

Certificate

MDD Annex II (excluding section 4)·MHL Healthcare Limited·DNV Product Assurance AS·15 Basic UDI-DIs

CE665104

Certificate

IVDD Annex IV (excluding sections 4, 6)·IBL International GmbH·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

Infant Supine Sleep System

FDA classification

FDA Class 2 ·Infant Supine Sleep System

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714003462·Coverslips

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714003479·IgG FITC Conjugate

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714002182·IgG FITC Conjugate w/ Evans Blue

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714004308·Phosphate Buffered Saline

IMMCO DIAGNOSTIC

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714004186·Counterstain

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714003318·Negative Control

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714004315·Serum Diluent