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Immunochemistry (immunology)
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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
ReferrIL Urine Albumin
Instrumentation Laboratory SpA
·
,
Italy
Class B
CE/IVDR
AutoLumo sIgE Calibrators
Autobio Diagnostics Co., Ltd.
·
,
China
Class B
CE/IVDR
T4 Calibrators
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
FT3 Calibrators
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
B·R·A·H·M·S uE3 KRYPTOR QC
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
B·r·a·h·m·s Ca 15-3 Kryptor Cal
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
Access Progesterone II Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
B·R·A·H·M·S MR-proADM II KRYPTOR CAL
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
β2-Microglobulin Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Anti-thyroglobulin antibodies (Anti-TG) Calibrators (Chemiluminescent Immunoass…
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
B·R·A·H·M·S MR-proANP KRYPTOR CAL
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
T4 Calibrators
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
FT4 Calibrators
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
B·R·A·H·M·S CgA II KRYPTOR CAL
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
GUDID
on market
B·r·a·h·m·s Papp-A Kryptor Cal
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
Access RUBELLA IgG QC
Beckman Coulter, Inc.
·
,
United States
IVD Annex II List B
FDA 510(k)
K250588
Active
Cleared 17 Nov 2025
CE/IVDD
+1
authorizations
Access hFSH Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Access Thyroglobulin Antibody II Calibrators
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Immunochemistry Systems CAL 2 Calibrator 2
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
B·r·a·h·m·s Cea Kryptor Cal
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
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