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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Controls - immunochemistry
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Controls- immunochemistry - other
Controls- immunochemistry - other
W0102152099
219 devices
CLIA IL-6 Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Respiratory Syncytial Virus Control
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Access AMH QC
Immunotech SAS
·
,
France
Class B
CE/IVDR
Negative Control
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
β2-Microglobulin Control
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
HbA1c Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
iPTH Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Strep A Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
IDS-iSYS Cartridge Check System (CCS)
Immunodiagnostic Systems SA
·
,
Belgium
Class A
CE/IVDR
GUDID
on market
Pathtrol™ Tryptase High Positive Control
Eurobio Scientific UK Ltd
·
,
United Kingdom
IVD General
CE/IVDD
B·R·A·H·M·S uE3 KRYPTOR CAL
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
Anti-CCP Control
Medcaptain Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Access Toxo IgM II QC
Beckman Coulter, Inc.
·
,
United States
IVD Annex II List B
FDA 510(k)
K242095
Active
Cleared 11 Oct 2024
CE/IVDD
+1
authorizations
Influenza A+B Ag Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
HbA1c Control
Heavybio, Inc
·
,
China
IVD General
CE/IVDD
Vigil Serology Control Level 3
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
ImmunoCAP ECP Control
Phadia AB
·
,
Sweden
Class B
CE/IVDR
ImmunoCAP Specific IgE Negative Control
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Finecare
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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