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Panels › Clinical Chemistry › Product code CFT · Class 1

Radioimmunoassay, Prolactin (Lactogen)

Regulation 862.1625

0510(k)s in 12 months (80 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
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Top companies in CFT

Company510(k)sRecalls
Diagnostic Products Corp.60
Abbott Laboratories50
Hybritech, Inc.40
Amersham Corp.30
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Leeco Diagnostics, Inc.30
Medix Biotech, Inc.30
Abbott Mfg., Inc.20
Bio-Rad Laboratories, Inc.20
Boehringer Mannheim Corp.20
DateFirm and productCodeLinked 510(k)
Mar 25, 2022Ortho-Clinical Diagnostics, Inc
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Open, Classified		 CFTK970281
Jul 12, 2018Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Open, Classified		 CFTK970281
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Terminated		 CFTNone listed
May 5, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Prolactin (PRL) Flex reagent cartridge
Terminated		 CFTNone listed
Sep 19, 2012Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654
Terminated		 CFTK904714
Apr 20, 2011Beckman Coulter Inc.
Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human
Terminated		 CFTK960561

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