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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Individual and specific hormones / proteins
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Bone and mineral metabolism assays
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Parathyroid hormone intact
Parathyroid hormone intact
W0102060312
78 devices
CL AIA-PACK Intact PTH ADJUSTER SET
Tosoh Corporation
·
,
Japan
IVD General
CE/IVDD
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Access Intact PTH Reagent Pack
Open recall
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K232791
Active
Cleared 1 Mar 2024
CE/IVDR
+1
authorizations
Elsa-Pth
Cisbio Bioassays
·
,
France
IVD General
CE/IVDD
IDS-iSYS Intact PTH
Immunodiagnostic Systems Limited
·
,
United Kingdom
IVD General
FDA 510(k)
K103325
Active
Cleared 3 Feb 2012
CE/IVDD
+1
authorizations
ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION
Tosoh Corporation
·
,
Japan
IVD General
CE/IVDD
GUDID
on market
Intact PTH (Parathyroid Hormone) ELISA
Biomerica, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
iPTH
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Parathyroid hormone (PTH)Determination Kit (Chemiluminescence Immunoassay)
Shenzhen Channel Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Intact Parathyroid Hormone Kit (CLIA)
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Parathyroid Hormone (PTH) Assay Kit (Chemiluminescent Microparticle Immunoassay)
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
Parathyroid Hormone (Electrochemiluminescence Immunoassay)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
Class B
CE/IVDR
Hokapi™ Pth
Suzhou Hokapi Biomedical Engineering Co., Ltd..
·
,
China
Class B
CE/IVDR
Intact Parathyroid Hormone（iPTH）Detection Kit（Magnetic Solid Phase Chemilumines…
Biobase Diagnostic Technology (Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Parathyroid Hormone CLIA Kit (Chemiluminescence Immunoassay)
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class B
CE/IVDR
Vidas® Pth (1-84)
Biomerieux SA
·
,
France
Class B
CE/IVDR
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Intact Parathyroid Hormone（iPTH）Detection Kit（Magnetic Solid Phase Chemilumines…
Biobase Diagnostic Technology (Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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