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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Bone and mineral metabolism assays
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Bone metabolism tests - other
Bone metabolism tests - other
W0102060399
23 devices
Devices
Access 25(OH) Vitamin D Total Reagent Pack
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Human COMP® ELISA
Immunodiagnostic Systems Limited
·
,
GB
IVD General
CE/IVDD
Beta-CrossLaps Chemiluminescence Immunoassay Kit
Nanjing RealMind Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Ostase® BAP EIA
Immunodiagnostic Systems Limited
·
,
GB
Class B
CE/IVDR
GUDID
on market
total sRANKL ELISA
Immundiagnostik AG
·
,
DE
IVD General
CE/IVDD
Beta-CrossLaps Chemiluminescence Immunoassay Kit
Nanjing RealMind Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Vdbp Elisa
Immundiagnostik AG
·
,
DE
IVD General
CE/IVDD
IDK® Osteoprotegerin ELISA
Immundiagnostik AG
·
,
DE
IVD General
CE/IVDD
Trypsinogen 2 Test Cassette (Lateral Flow Method)
Beijing Applied Biological Technologies Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Beta-CrossLaps Chemiluminescence Immunoassay Kit
Nanjing RealMind Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Beta-CrossLaps Chemiluminescence Immunoassay Kit
Nanjing RealMind Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Access 25(OH) Vitamin D Total (Reagent Pack)
Beckman Coulter, Inc.
·
,
US
Class B
FDA 510(k)
K223503
Active
Cleared 19 Jan 2023
CE/IVDR
+1
authorizations
Trypsinogen 2 Test Cassette (Lateral Flow Method)
Beijing Applied Biological Technologies Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Access 25(OH) Vitamin D Total Reagent Pack
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Bone R-hydroxy Glutamic Acid Protein (BGP) Test
Beijing Jinwofu Bioengineering Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Urine CartiLaps® (CTX-II) EIA
Immunodiagnostic Systems Limited
·
,
GB
Class B
CE/IVDR
GUDID
on market
β-Crosslaps(β-CTx) Assay Kit (Chemiluminescent Immunoassay)
Sichuan Orienter Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Beta-CrossLaps Chemiluminescence Immunoassay Kit
Nanjing RealMind Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Total type I Collagen Amino Terminal Lengthening Peptide(P1NP) Assay Kit (Chemi…
Sichuan Orienter Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
IDS-iSYS Ostase® BAP
Immunodiagnostic Systems Limited
·
,
GB
IVD General
CE/IVDD
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