ClearanceBrief
Product code MAQ ยท Class 3

Kit, Dna Detection, Human Papillomavirus

0510(k)s in 12 months (0 all time)
1recalls in 12 months (12 all time)
1recalls that name a 510(k)
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Top companies in MAQ

Company510(k)sRecalls
Digene Corp04
Becton Dickinson & Co.02
Roche Molecular Systems, Inc.02
Abbott Molecular, Inc.01
Beckman Coulter Inc01
GET TESTED INTERNATIONAL AB01
Ventana Medical Systems Inc01
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
HPV Antigen Test
Open, Classified		 MAQNone listed
Jul 23, 2025Becton Dickinson & Co.
BD COR System Software. Model Number: 444829.
Open, Classified		 MAQNone listed
Dec 3, 2024Becton Dickinson & Co.
BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
Open, Classified		 MAQNone listed
Oct 29, 2024Abbott Molecular, Inc.
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Open, Classified		 MAQNone listed
Nov 19, 2020Roche Molecular Systems, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro di
Terminated		 MAQNone listed
Sep 14, 2018Ventana Medical Systems Inc
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated		 MAQNone listed
Sep 10, 2013Roche Molecular Systems, Inc.
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA
Terminated		 MAQNone listed
Nov 19, 2003Beckman Coulter Inc
Coulter DNA Prep Reagents Kit Part 6607055
Terminated		 MAQNone listed
Mar 19, 2003Digene Corp
Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).
Terminated		 MAQK990023
Mar 19, 2003Digene Corp
Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296
Terminated		 MAQNone listed
Mar 19, 2003Digene Corp
Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.
Terminated		 MAQNone listed
Mar 19, 2003Digene Corp
Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
Terminated		 MAQNone listed

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