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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry controls/standards/calibrators
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Multicomponent immunochemistry controls
Multicomponent immunochemistry controls
W01021521
278 devices
Liver Fibrosis Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Seronorm® Immunoassay Liq L-1
Sero As
·
,
Norway
IVD Annex II List B
CE/IVDD
W01021521
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Custom Liquid Immunoassay Control - Level 1
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
Anti-thyroid Antibodies Control
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Check-P Control
Zybio Inc.
·
,
China
Class C
CE/IVDR
Inflammation Markers Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Check-P Control
Zybio Inc.
·
,
China
Class C
CE/IVDR
PCT/CRP Control
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Access MeMed BV QC (Kit)
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
Immune Multiple Composite Quality Control
Sichuan Orienter Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Custom Liquid Immunoassay Control - Level 2
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
DRI Multi-Drug Urine Calibrator 4
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Autonorm® Immunoassay Liq L-1
Sero As
·
,
Norway
IVD Annex II List B
CE/IVDD
Immunoassay Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Hypertension Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
MAS Liquimmune Liquid Assayed Immunoassay Control
Microgenics Corporation
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
Microgenics Corporation
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control
Microgenics Corporation
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
DRI Negative Alcohol Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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