ClearanceBrief
Panels › Clinical Chemistry › Product code DHA · Class 2

System, Test, Human Chorionic Gonadotropin

Regulation 862.1155

0510(k)s in 12 months (72 all time)
0recalls in 12 months (14 all time)
11recalls that name a 510(k)
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Top companies in DHA

Company510(k)sRecalls
Abbott Laboratories51
Dade Behring, Inc.32
Siemens Healthcare Diagnostics, Inc.23
Germaine Laboratories, Inc.40
Diagnostic Products Corp.30
Nichols Institute Diagnostics12
Ortho Clinical Diagnostics21
Roche Diagnostics30
Azog, Inc.20
Baxter Healthcare Corp20
DateFirm and productCodeLinked 510(k)
Jan 17, 2023Abbott Laboratories
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Open, Classified		 DHAK170317
Feb 22, 2022Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Open, Classified		 DHAK990222
Nov 21, 2018Abbott Ireland Diagnostics Division
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Terminated		 DHAK170317
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
Terminated		 DHAK863861
Feb 18, 2016Ortho-Clinical Diagnostics
1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrator
Terminated		 DHAK063720
Jan 7, 2016Siemens Healthcare Diagnostics Inc
Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
Terminated		 DHAK060548
Jan 7, 2016Siemens Healthcare Diagnostics Inc
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
Terminated		 DHAK060548
Mar 11, 2011BioCheck Inc
Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Terminated		 DHANone listed
Mar 11, 2011BioCheck Inc
Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Terminated		 DHANone listed
May 19, 2006Dade Behring , Inc.
Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic.
Terminated		 DHAK003696
May 19, 2006Dade Behring , Inc.
Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.
Terminated		 DHAK003696
Oct 6, 2005Nichols Institute Diagnostics
Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
Terminated		 DHAK042676
Oct 6, 2005Nichols Institute Diagnostics
Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
Terminated		 DHANone listed
Nov 30, 2004DPC Cirrus
Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
Terminated		 DHAK033234

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