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Standards and calibrators immunochemistry
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Standards and calibrators - immunochemistry - other
Standards and calibrators - immunochemistry - other
W0102152299
146 devices
Access RUBELLA IgG Calibrators
Beckman Coulter, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
Access IL-6 (Calibrators)
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
Anti-thyroid peroxidase antibodies (Anti-TPO) Calibrators (Chemiluminescent Imm…
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Access HBs Ag Calibrators
Beckman Coulter, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
Access hLH Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Access Free T4 Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Access TPO Antibody Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K240469
Active
Cleared 9 Aug 2024
CE/IVDR
+1
authorizations
Access Total T3 Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
IDS-iSYS 25 VitDS Calibrator Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
Class B
CE/IVDR
GUDID
on market
Access Progesterone Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Access HBs Ab Calibrators
Beckman Coulter, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
Access HAV IgM Calibrators
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
Cormay Immuno-Multical
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
C-reactive protein (CRP) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Access SHBG Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
MALB Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Access HBc Ab Calibrators
Beckman Coulter, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
Access Prolactin (Calibrators)
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
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